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 Chest Pain (1776); Coagulation Disorder (1779); Pneumonia (2011); Hematuria (2558); Test Result (2695)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

On (b)(6) 2015, a phone call was received from the caller/end user alleging a variance between the inratio inr result and the laboratory inr result.The following information was received: historical inratio results: (b)(6) 2015: inr=3.0 (normal warfarin dose was taken).(b)(6) 2015: inr=2.3 (normal warfarin dose was taken).Therapeutic range: 2.0 - 3.0.The caller was diagnosed with pneumonia and prescribed antibiotics (levoquin) on (b)(6) 2015.On (b)(6) 2015, the caller performed a routine inratio inr test with a 2.6 result.Her normal warfarin dose of alternating 10mg and 12mg/day was taken.All inratio tests were performed on the caller's bed.Later the same day, (b)(6) 2015, she presented to the hospital with chest pain, pneumonia and blood in urine.The laboratory inr was 5.8.There was 5 hours between the inratio inr and the laboratory inr.The caller was administered vitamin k and her warfarin dose was held.Upon admittance to the hospital, an electrocardiogram (ekg), echocardiography (echo) and blood tests were performed which she reports as "normal." there was no inratio testing performed while hospitalized.On (b)(6) 2015, the caller was discharged from the hospital with a laboratory inr result of 2.0 and returning to a normal warfarin dose of alternating 10mg and 12mg.On (b)(6) 2015, the laboratory inr result was 2.2.On (b)(6) 2015, an alternate point of care (poc) inr result was 2.1.On (b)(6) 2015, a routine inratio inr result was 2.2.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing history for strip lot 373678a was performed and met release criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was reported to have the medical conditions of rheumatoid arthritis, lupus, antiphospholipid syndrome, pneumonia, and a history of anemia.These conditions may impact the performance of the assay.The customer had reported that the all the inratio tests were performed on their bed.It was not clarified whether or not their bed was a level surface.Per product user guide, "test with the monitor on a level surface that is free of vibrations.Testing on an uneven surface or shaking may cause inaccurate results.Do not hold the monitor in your hand while running a test." testing on an uneven surface can impact the sample migration, resulting in error messages or inaccurate results.Although a user issue was identified in the complaint, the root cause cannot be fully determined from the information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5307293
• MDR Text Key: 33791129
• Report Number: 2027969-2015-01014
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 373678A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention