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 12/29/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable results from coaguchek inrange meter, serial number (b)(6), compared to a laboratory result using an unknown method.On 29-dec-2023, the meter result was 4.3 inr.The laboratory result within 3 hours was 6.0 inr.On an unknown date, the meter result was 4.3 inr.The laboratory result within 3 hour was 3.0 inr.The patient¿s therapeutic range is 2 -3 inr.

Manufacturer Narrative

No product is expected to be returned for investigation.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.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.".

Manufacturer Narrative

The customer received a new coaguchek meter and performed their own laboratory result comparisons.The comparison results were acceptable.No product problem was identified.

• 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: 18596411
• MDR Text Key: 334800291
• Report Number: 1823260-2024-00244
• 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,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Sex: Male