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

Catalog Number ASKU

Device Problems Circuit Failure (1089); High Test Results (2457)

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

Event Date 11/16/2020

Event Type  malfunction  

Event Description

There was an allegation of questionable results from coaguchek inrange meter serial number (b)(4) compared to laboratory results using a sysmex ca-500 analyzer with siemens reagents.The laboratory results were all performed within an hour of the meter results.The patient's therapeutic range is 2.0-3.0 inr.

Manufacturer Narrative

Occupation is patient/consumer.It was alleged that the meter has recently been displaying an error message (meter defective).The meter and test strips were requested for investigation.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.".

Manufacturer Narrative

The returned test strips were measured with the returned meter with a high level control sample.Testing results (qc range = 2.5 - 3.1 inr): returned strip: qc 1: 2.9 inr, qc 2: 2.8 inr, qc 3: 2.8 inr.1 strip seemed to have been inserted into the meter several times.Strong vertical abrasions were visible on the gold side.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred during investigation of the returned customer test strips.The returned meter was powered on without any error messages.The meter data and error memory were reviewed.The meter's error memory showed error e-51 (442, 450, 442, meter self-check detected a general error).The investigation observed a frequent alternation of self-test errors and measurements in the meter's logs.No abnormalities in the measured values were observed.The device correctly recognized the errors and no measurement was carried out that might have lead to an incorrect measurement result.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13588138
• MDR Text Key: 292717107
• Report Number: 1823260-2022-00489
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• 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 Age: 82 YR
• Patient Sex: Male