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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 06/17/2015

Event Type  Injury  

Event Description

Caller alleging discrepant inratio value.Patient's therapeutic range 2.5 - 3.5 (b)(6) 2015 coaguchek inr = >8; inratio inr = 4.9; lab inr = 9.8 a couple of minutes between the coaguchek and inratio.Lab draw performed 30 minutes after inratio.No hospitalization.Based on the lab result of 9.8 on (b)(6) 2015, physician withheld coumadin and recommended patient self tester eat some spinach.Patient self tester resumed coumadin on (b)(6) 2015 at 10mg.Patient has used his inratio 2 test 2x since reporting the discrepancy.On (b)(6) 2015 he tested on his inratio and the result was inr = 1.6.Within a couple minutes he had als.O tested on his coaguchek and obtained an inr = 1.4.The second time the customer used his inratio to test was (b)(6) 2015 inratio inr = 1.7, no comparison was made on the coaguchek that day.No additional information provided.

Manufacturer Narrative

Investigation conclusion: investigation pending.

Manufacturer Narrative

Investigation conclusion update: 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 was performed.In-house testing results met both accuracy and strip repeatability criteria.After reviewing all historical in-house testing for lot 357499, no product deficiency was found for this lot.Although a relevant nc was noted in the batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.Since the meter was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Root cause is unable to be determined at this time without product return.Capa-(b)(4) was initiated to investigate the cause of highly discrepant results.Further investigation into this issue is being performed under capa-(b)(4).

• 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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4916717
• MDR Text Key: 15587278
• Report Number: 2027969-2015-00515
• 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: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 357499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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: FISH OIL; HYDROCHLOROTHIAZIDE; ALLOPURINOL; VITAMIN B12; CALCIUM AND VITAMIN D; COZAAR; PROCARDIA; LOPRESSOR; KEPPRA; NEXIUM; COUMADIN; MULTIVITAMIN; NIACIN
• Patient Outcome(s): Required Intervention