MAUDE Adverse Event Report: ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100139

Device Problems Inadequacy of Device Shape and/or Size (1583); Low Test Results (2458)

Patient Problems Swelling (2091); Thrombosis (2100)

Event Date 10/10/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the lab inr result.Patient is a (b)(6) male, who initially developed left lower extremity deep vein thrombosis (dvt) on (b)(6) 2014 and started on warfarin.On (b)(6) 2014, inr was 8.5.The warfarin was held and patient was administered vitamin k 1mg and one (1) unit of blood.On (b)(6) 2014, the patient's inratio inr was 0.8 therapeutic range was 1.5-2.5.Reportedly, the finger was "milked" by the nurse and incorrect size lancet was used to perform the test.The nurse evaluated the patient and noted swelling of the left lower extremity.The patient was sent to the emergency room for evaluation.Per hosp records, the ultrasound (us) showed acute on chronic dvt, given supratherapeutic inr (5.26) at the time of dvt formation/expansion, this is likely a failure of warfarin.Hematocrit was 26.0%.The patient was hospitalized and treatment included: holding of warfarin and adminstration of enoxaparin.The following day, (b)(6) 2014, the inr was 2.07 and 1.78.On (b)(6) 2014, the inr was down to 1.36 and the patient was discharged home on (b)(6) 2014 on enoxaparin 80mg daily.At the time of the call, the patient was reported to be in good condition.There was no additional info provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation.Although the customer did not provide the actual lot number used at the time of the discrepant result, the strip code entered into the monitor was used to identify a lot number that the customer had used with the monitor.The lot was used for internal investigation purposes to evaluate the performance of the inratio pt/inr monitoring system.The complaint of discrepant low results was not replicated with the returned monitor using retain strips.However, discrepant high results were obtained during the investigation.Further investigation into this issue will be pursued under (b)(4).The manufacturing records for lot number 344683 were reviewed.The lot met specifications and no non-conformances were documented.This lot met release specifications.The impedance curve for the inratio inr result of 0.8 was not retrieved.The monitor retains up to the last 4 impedance curves.Because the inr result was not present in the last 4 results, impedance curve analysis was not performed.Our capa investigation ((b)(4)) has determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to discrepant inr results.The customer reported bladder cancer as well as a hematocrit of 26%.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is the patient medical conditions of bladder cancer and a hematocrit of 26% which may have contributed to the discrepant low results reported by the customer.Further investigation into these issues will be pursued under (b)(4).

Manufacturer Narrative

Investigation/conclusion update: in addition to the previously reported investigation performed on 01/22/2015, the following information has been added.During investigation of the customer's returned monitor an additional strip lot number 344684 was identified, in addition to the previously reported strip lot number 344683.The manufacturing records, for lot number 344683, were also reviewed and no relevant non-conformances were documented.The lot also met release specifications.A review of previously performed in-house testing data on lot number 344684 did not reveal any product deficiencies.All replicates were within the allowable difference for accuracy and repeatability.The customer reported bladder cancer as well as a hematocrit of 26%.Our capa investigation (capa-(b)(4)) has determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to discrepant inr results.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is the patient medical conditions of bladder cancer and a hematocrit of 26% which may have contributed to the discrepant low results reported by the customer.In addition to the medical conditions identified in the complaint, improper techniques were reported.The improper techniques cannot be ruled out as a possible root cause for the unexpected results.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4255614
• MDR Text Key: 5107358
• Report Number: 2027969-2014-01002
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN: 1000MG EVERY 6HRS AS NEEDED,; OMEPRAZOLE 40MG DAILY,; TRAZODONE HCL 150MG AT BED.; PREDNISOLONE ACETATE: 1%,1 DROP 4X DAILY,; KETOROLAC TROMETHAMINE: 0.5%,1 DROP 4X DAILY,; DEXAMETHASONE: 12MG DAILY,; PHYTONADIONE (VIT. K): 1MG, DATE:; METOPROLOL TARTRATE 12.5MG DAILY,; MULTIVITAMIN DAILY,; ONDANSETRON HCL 8MG DAILY,; PROCHLORPERAZINE MALEATE:10MG EVERY 6HRS AS NEEDED; ATORVASTATIN CALCIUM: 10MG DAILY,; 1-4 TABLETS 2X DAILY AS NEEDED,; MAGNESIUM OXIDE: 280MG 2X DAILY,; WARFARIN: 5MG DAILY,; DOCUSATE NA 50MG/SENNOSIDES 8.6MG -; LIDOCAINE: 5% OINTMENT 3X DAILY,; INRATIO MONITOR, SN: (B)(4),; EPOETIN ALFA, RECOMB 40,000 UNITS/ML WEEKLY,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86