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

Model Number HS99007G1

Device Problems Device Issue (2379); High Test Results (2457)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Caller alleging discrepant inratio values.Event occurred in (b)(6).(b)(6) 2015 inratio = 4.3 ; lab = 2.5; four hours between inratio test and lab.(b)(6) 2015 inratio = 4.9; repeat inratio = 5.4; time between tests unknown.Patient's therapeutic range: 2-3.Patient reported having an operation three weeks prior and recently suffered from the flu.Nature of operation and dates of hospitalization undisclosed.No additional information provided.

Manufacturer Narrative

Investigation conclusion update: 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 release specification is within the calculated confidence interval of the percent flier rate for complaint investigation testing.No product deficiency was found for lot k363299.Although a relevant nc was noted in 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.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.

• 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: 5022050
• MDR Text Key: 24680183
• Report Number: 2027969-2015-00610
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HS99007G1
• Device Lot Number: K363299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• 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