MAUDE Adverse Event Report: BBI SOLUTIONS OEM LTD CLEARVIEW SIMPLIFY D-DIMER

Model Number 505285

Device Problem False Negative Result (1225)

Patient Problem Thromboembolism (2654)

Event Date 10/26/2015

Event Type  No Answer Provided  

Manufacturer Narrative

No return devices from the user were made available for testing at bbi solutions at the time of this report.All tests on retained pouched devices from pouch lot 1022-33816 (used to produce kit batch (b)(4)) ran satisfactorily with no flow issues or deterioration in sensitivity.Testing of the devices did not indicate any gross deterioration in performance.All in-process qc testing during manufacture did not identify any errors in manufacture, and no non-conformances, deviations or any out of trend qc results were noted, from manufacturing and quality control records, that would indicate any performance issues with the batch of pouched devices.Overall assessment of the product sensitivity at the time of manufacture and subsequent testing indicates that the sensitivity of lot 1022-33816 was above the cut off limit and meets bbi's expectation for normally expected product performance.Patient management can vary considerably (e.G.: from sending the patient home, to sending them to hospital for imaging) depending on the wells score in combination with the result of the d-dimer test.It is therefore important to note that the clearview simplify d-dimer test must be used in conjunction with the full clinical context of the patient.The performance characteristics detailed in the product ifu do not claim 100% sensitivity or specificity; therefore there is a known low level of possible false negative and false positive results.It is noted in this case, from the complaint questionnaire, that the patient's dvt was located in the calf.A paper by keeling et al (british journal of haematology 2004; 124: 15-25) states that, in a review of the performance of several qualitative d-dimer tests, isolated calf dvts only have a 16-67% assay sensitivity, compared to all other types of dvts which result in 80-94% assay sensitivity.Although clearview simplify d-dimer was not included in the study, it is reasonable to expect that the sensitivity of clearview simplify d-dimer is also reduced for isolated calf dvts, as this test is also qualitative.Calf vein thrombi can result in minimal fibrinolysis which can cause possible false negatives.Therefore in line with contemporary diagnostic algorithms for suspected dvt/pe, high probability patients are not safe to exclude from further testing based on the results of d-dimer tests alone.Bbi do not recommend that d-dimer tests be used as stand-alone tests for exclusion of dvt/pe.This is the reason that the product insert claims that the test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation (dic), deep vein thrombosis (dvt), and pulmonary embolism (pe).No clinical diagnosis should be based on the result of clearview simplify d-dimer alone.Clinical signs and other relevant test information should be included in the diagnostic decision.It is possible that the time the patient samples were taken could also account for the false negative result with clearview simplify d-dimer.At the time of the first capillary sample being taken (patient had been symptomatic for one week), the patient's d-dimer level may have been below the cut-off of the clearview simplify d-dimer test, resulting in a negative result.There needs to be active fibrinolysis for a positive result on the clearview simplify.D-dimer has a half-life of approximately 6 hours in the circulation of individuals with normal renal function.Patients with stabilised clots and not undergoing active fibrin deposition and plasmin activation, may not give detectable d-dimer elevations.The size of the clot could also have an effect on whether the d-dimer can be detected - a smaller clot would produce lower levels of d-dimer which could be below the cut-off of the clearview simplify d-dimer test.In conclusion, in this case of false negative results with the clearview simplify d-dimer, the likely root cause is that the negative result was obtained in line with the expected low level of false negative results with this test.

Event Description

The patient presented at gp with left calf pain and had been symptomatic for one week, and was otherwise well and healthy.The wells score was 1.The patient's capillary blood sample was tested on the clearview simplify d-dimer test (batch (b)(4)) and a negative result was obtained.The patient was then sent to hospital where an ultrasound detected a popliteal deep vein thrombosis (dvt).No detrimental effects were suffered by the patient.

Manufacturer Narrative

This follow-up report provides testing data from return devices from the same kit, from the user.The actual device used was discarded, however two pouched devices remaining in the kit box were returned to bbi solutions on 03 dec 2015.Both devices were tested with two d-dimer positive samples from the standard qc release panel that contain the lowest levels of d-dimer.All tests on returned pouched devices from pouch lot 1022-33816 ran satisfactorily with no flow issues or deterioration in sensitivity.Testing of the devices did not indicate any gross deterioration in performance.All tests on returned and retain pouched devices from pouch lot 1022-33816 ran satisfactorily with no flow issues or deterioration in sensitivity.Testing of the devices did not indicate any gross deterioration in performance.All in-process qc testing during manufacture did not identify any errors in manufacture, and no non-conformances, deviations or any out of trend qc results were noted, from manufacturing and quality control records, that would indicate any performance issues with the batch of pouched devices.Overall assessment of the product sensitivity at the time of manufacture and subsequent testing indicates that the sensitivity of lot 1022-33816 was above the cut off limit and meets bbi's expectation for normally expected product performance.Patient management can vary considerably (e.G.: from sending the patient home, to sending them to hospital for imaging) depending on the wells score in combination with the result of the d-dimer test.It is therefore important to note that the clearview simplify d-dimer test must be used in conjunction with the full clinical context of the patient.The performance characteristics detailed in the product ifu do not claim 100% sensitivity or specificity; therefore there is a known low level of possible false negative and false positive results.It is noted in this case, from the complaint questionnaire, that the patient's dvt was located in the calf.A paper by keeling et al (british journal of haematology 2004; 124: 15-25) states that, in a review of the performance of several qualitative d-dimer tests, isolated calf dvts only have 16-67% assay sensitivity, compared to all other types of dvts which result in 80-94% assay sensitivity.Although clearview simplify d-dimer was not included in the study, it is reasonable to expect that the sensitivity of clearview simplify d-dimer is also reduced for isolated calf dvts, as this test is also qualitative.Calf vein thrombi can result in minimal fibrinolysis which can cause possible false negatives.Therefore in line with contemporary diagnostic algorithms for suspected dvt/pe, high probability patients are not safe to exclude from further testing based on the results of d-dimer tests alone.Bbi do not recommend that d-dimer tests be used as stand-alone tests for exclusion of dvt/pe.This is the reason that the product insert claims that the test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation (dic), deep vein thrombosis (dvt), and pulmonary embolism (pe).No clinical diagnosis should be based on the result of clearview simplify d-dimer alone.Clinical signs and other relevant test information should be included in the diagnostic decision.It is possible that the time the patient samples were taken could also account for the false negative result with clearview simplify d-dimer.At the time of the first capillary sample being taken (patient had been symptomatic for one week), the patient's d-dimer level may have been below the cut-off of the clearview simplify d-dimer test, resulting in a negative result.There needs to be active fibrinolysis for a positive result on the clearview simplify.D-dimer has a half-life of approximately 6 hours in the circulation of individuals with normal renal function.Patients with stabilised clots and not undergoing active fibrin deposition and plasmin activation, may not give detectable d-dimer elevations.The size of the clot could also have an effect on whether the d-dimer can be detected - a smaller clot would produce lower levels of d-dimer which could be below the cut-off of the clearview simplify d-dimer test.In conclusion, in this case of false negative results with the clearview simplify d-dimer, the likely root cause is that the negative result was obtained in line with the expected low level of false negative results with this test.

• Brand Name: CLEARVIEW SIMPLIFY D-DIMER
• Type of Device: CLEARVIEW SIMPLIFY D-DIMER
• Manufacturer (Section D): BBI SOLUTIONS OEM LTD; 8 tom mcdonald avenue; medipark; dundee, dundee DD2 1 NH; UK DD2 1NH
• Manufacturer (Section G): BBI SOLUTIONS OEM LTD; 8 tom mcdonald avenue; medipark; dundee, dundee DD2 1 NH; UK DD2 1NH
• Manufacturer Contact: sarah paterson ; 8 tom mcdonald avenue; medipark; dundee, dundee DD2 1-NH ; UK DD2 1NH ; 1382561000
• MDR Report Key: 5261018
• MDR Text Key: 32504828
• Report Number: 3006717351-2015-00002
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 505285
• Device Lot Number: PT142A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other