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

Model Number 99008G1

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, therapeutic donor testing was performed.In-house testing on retained strip lot k385432 was found to be performing within expectations.The manufacturing records for the lot were reviewed and the lot met release specifications.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.

Event Description

Event occurred in (b)(6).Report received of discrepant inratio values.(b)(6).No additional information provided.

• 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: 6087842
• MDR Text Key: 59740964
• Report Number: 2027969-2016-00675
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2016

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: Lay User/Patient
• Device Model Number: 99008G1
• Device Lot Number: K385432
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• 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
• Treatment: CLAVIX; DELIX; DHEA; DIGITOXIN; EPLEMERON; INRATIO MONITOR SERIAL # (B)(4); MAGNESIUM; MELATONIN; PANTOPRAZOL; TIOBLES; TORASIMED; VITAMIN B