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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Patient Problem/Medical Problem (2688)

Event Date 04/24/2015

Event Type  Injury  

Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab inr result.The results are as follows: (b)(6) inratio = 2.2 (b)(6) lab inr = 8.4 time between tests: 21 days.Therapeutic range was not provided, patient self tester and nurse stated the meter results have ranged from 1.9 to 3.1; has been testing since (b)(6) 2012.On (b)(6) 2015 patient self tester presented to hospital with shortness of breath (no bleeding or bruising) and the lab draw resulted as inr= 8.4.Patient was admitted for pleural effusion; the pleural tap showed bloody fluid.Patient self tester discharged on (b)(6) with "all blood work normal" - no further information such as lab draw methodology or other lab results will be able to be provided.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of the event (shortness or breath).The last inratio inr was twenty-one (21) days prior to the event.The coagulation status can significantly change during this period of time.Based on the inability to rule out the possibility that the device may have caused or contributed to the bloody pleural fluid, this event is conservatively reported as a serious injury based on the blood in the pleural fluid being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Invesetigation pending.

Manufacturer Narrative

When patient was hospitalized and the lab inr=8.4, the patient was given vit.K and antibiotics.This information was inadvertently omitted from the initial report.Investigation and conclusion: the meter and strips associated with the complaint were returned for investigation.The customer's complaint of discrepant low results was not confirmed during in-house testing.Return and retain strips tested on the returned meter met both accuracy and repeatability criteria.After reviewing all previous in-house testing conducted for lot 362568a, no product deficiency was found for this lot.The release specification is within the calculated confidence interval of the percent flier rate for complaint investigation testing.A review of the manufacturing records for lot 362568a did not uncover any relevant non-conformances.The lot meets release specification.Certain relevant conditions, such as advanced stage cancer and inflammatory conditions have been identified to contribute to discrepant inr results.The customer reported having pleural effusion and a history of cancer.A notification letter has been sent to customers to inform them of these patient conditions.The returned meter met both accuracy and repeatability criteria and passed functional and thermistor testing during an in-house investigation.The impedance curve associated with the customer's result was statistically analyzed and was found to be normal in shape and does not exhibit weak-slope change or other abnormalities in shape.There was no information that suggests there is a product deficiency with the meter.Root cause is unable to be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4876477
• MDR Text Key: 6043166
• Report Number: 2027969-2015-00452
• 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: Consumer,Distributor,consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 362568A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• 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
• Patient Sequence Number: 1
• Treatment: MILK THISTLE 1 TABLET/DAY; ROBAXIN 500 MG AS NEEDED; LIPITOR; RASPBERRY KETONE; COUMADIN 2.5 MG/DAY; FOLID ACID; METOPROLOL TARTRATE; LEVOTHYROXINE; MULTI-VITAMIN DAILY; COQ10 300 MG/DAY; ALBUTERAOL NEBULIZER USED; CALTRATE WITH VITAMIN D; AMIODARONE; ACIDOPHILUS; LOSARTAN
• Patient Outcome(s): Hospitalization; Required Intervention