MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME MONITOR

Catalog Number 07671687016

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The test strips' expiration date was not provided.The coaguchek inrange meter serial number was (b)(6).No product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.E3 - occupation was patient's/consumer's wife.

Event Description

We received an allegation of questionable inr results for 1 patient tested with a coaguchek inrange meter when compared to a different coaguchek inrange meter.On the morning of(b)(6) 2024, the patient had a laboratory result of 3.01 inr.At the "end of that afternoon", he had a meter result of 5.8 inr when tested on his meter and a result of 4.4 inr when tested on another coaguchek inrange meter.The timeframe between the test measurements was not provided.The patient's therapeutic range was not provided.

Manufacturer Narrative

A different coagucheck meter was provided to the patient to conduct a comparison with his coaguchek inrange meter.The results were requested for investigation but were not provided.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19054573
• MDR Text Key: 340459017
• Report Number: 1823260-2024-01057
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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 Catalogue Number: 07671687016
• Device Lot Number: 72293511
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male