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

Model Number 100139

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between inratio inr results and comparison to the lab inr results.The results were as follows: (b)(6): inratio=2.2, (b)(6): inratio=>7.5, lab=5.7, (b)(6): inratio=7.2, lab=5.3.The patient's therapeutic range: unknown.Multiple drops of blood were added when testing.No medication or diet changes between (b)(6) inratio=2.2 and (b)(6) inratio=: >7.5 results.Coumadin, 1.5mg/day; held for 2 days after 5.7 lab result on (b)(6); resumed on (b)(6).

Manufacturer Narrative

It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The release specification is within the calculated confidence interval of the percent flier rate for complaint investigation testing.A review of the manufacturing records indicated that the lot met release specification.Although an improper technique was identified, a root cause could not be determined without additional information.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: 5016094
• MDR Text Key: 24693278
• Report Number: 2027969-2015-00604
• 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: Health Professional
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 362444A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• 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