MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G2

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Caller alleging receiving discrepant inratio values: (b)(6) 2014, inratio 2.8, retest inratio 1.6, second retest inratio 2.5.One minute between each test.Customer using sample from venous draw for testing.Customer used pipette to apply sample to sample wall.Pt's therapeutic range unk.No reported adverse pt sequela.No additional info provided.

Manufacturer Narrative

Investigation/conclusion: 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.Retain strip testing results met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturer record for the lot did not uncover any relevant non-conformance.Lot meets release specification.An improper usage of the product was identified in the complaint.This cannot be ruled out as a cause for the error experienced.Customer was using expired product for testing.Using expired product may be a cause for the errors experienced by the customer.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4384036
• MDR Text Key: 19088545
• Report Number: 2027969-2014-01098
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2014

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: 99008G2
• Device Lot Number: 335553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/30/2014
• 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
• Removal/Correction Number: Z-1564-2014
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR: SERIAL # (B)(4)