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 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips, there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.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.Occupation ni equals lay user / patient.

Event Description

The initial reporter complained of a questionable high inr result from a coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The meter result was 5.3 inr and within 4 hours the laboratory result was 3.3 inr.The patient's therapeutic range is 2.0 - 3.0 inr.The laboratory result was deemed to be correct.The patient had a recent decrease in their dosage.The patient had a hematocrit of 30.7 percent.The patient does take plavix.

• 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: 9270730
• MDR Text Key: 219591303
• Report Number: 1823260-2019-03934
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 30497423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• 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
• Type of Device Usage: N
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 91