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

Catalog Number 04625358016

Device Problem Low Test Results (2458)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

The coaguchek inrange meter serial number was (b)(6).Section e3: occupation is patient/consumer.The meter and test strips were requested for investigation per the reporter's request.The 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.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.".

Event Description

The initial reporter complained of discrepant low inr results with a coaguchek inrange meter compared to an unknown laboratory method.On (b)(6) 2023 the result from the meter was 2.2 inr.The result from the laboratory was 2.89 inr.On (b)(6) 2023 the result from the meter was 2.3 inr.The result from the laboratory was 3.68 inr.On (b)(6) 2023 the result from the meter was 2.4 inr.The result from the laboratory was 3.73 inr.The timeframe between the meter and laboratory results was not provided.The patient¿s therapeutic range was not provided.

Manufacturer Narrative

The meter and test strips were received for investigation.The returned test strips were measured with the returned meter with a high-level control sample: testing results (qc range: 2.6 - 3.2 inr): qc 1: 2.9 inr.Qc 2: 3.0 inr.Qc 3: 2.9 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.The returned material and the retention material meet the specifications.The investigation did not identify a product problem.The cause of the event could not be determined.Section d9 was updated.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 18153893
• MDR Text Key: 328398414
• Report Number: 1823260-2023-03640
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 12/01/2023

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 Catalogue Number: 04625358016
• Device Lot Number: 67810013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 12/01/2023
• 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