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

Model Number 100139

Device Problem Low Test Results (2458)

Patient Problem Anemia (1706)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

The caller alleged a variance between the inratio inr result and the laboratory inr result.Results are as follows: date: (b)(6) 2015 inratio inr: n/a laboratory inr: 3.1 (b)(6) 2015, 2.2, n/a.Therapeutic range: 2.5 - 3.5.The patient was reported to be anemic.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the customer reported a discrepant low inratio inr result during testing.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 data was performed.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances and the lot met release specification.The patient was reported to be anemic, however, the hematocrit is unknown at the time of the complaint.The prior month, the hematocrit was reported to be 35.7.Anemia with a hematocrit less than 30% was identified as a condition that may contribute to discrepant inr results.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

(b)(4).

Event Description

Correction: the inratio inr result on the initial medwatch form was inadvertently reported as 2.2.The correct results are as follows: (b)(6) 2015: inratio inr=1.0.

• 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: 4779023
• MDR Text Key: 5803729
• Report Number: 2027969-2015-00347
• 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
• Type of Report: Initial,Followup
• Report Date: 04/22/2015

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: 362394A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• 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
• Treatment: WARFARIN; INRATIO MONITOR SN (B)(4)