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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation was lay user/patient.Unique device identifier (udi) (b)(4).The suspected products were requested to be returned for investigation, however, the strips were no longer available to return.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Test strip retention samples 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

We received a report of questionable results obtained on a coaguchek xs meter serial number (b)(4), compared to laboratory results utilizing an unknown analyzer and reagent.The meter result was 4.0 inr at 10:17 am.The laboratory result was 2.6 inr taken at approximately 2:00 pm.A second set of results was taken on (b)(6) 2021: the meter result was 4.3 inr at 9:48 am.The laboratory result was 3.0 inr taken at approximately 11:35 am.The laboratory results were believed on both days.The patient's therapeutic range was 2.3-3.5 inr, and the testing interval was every two weeks.

• Brand Name: COAGUCHEK XS SYSTEM
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11424303
• MDR Text Key: 246241949
• Report Number: 1823260-2021-00680
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2021

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49017421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/05/2021
• 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: 77 YR
• Patient Weight: 91