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

Model Number 99008G1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 02/02/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.

Event Description

The caller alleged a variance between the inratio inr result in comparison to the laboratory inr result.The results are as follows: inratio: 1.4.Laboratory: 2.2.No exact date(s) were provided; although requested, no further information was available including patient information.No therapeutic range was available.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL 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: 4899749
• MDR Text Key: 24382553
• Report Number: 2027969-2015-00494
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

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: 99008G1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/08/2015
• 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