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

Catalog Number 04625315003

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

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.The related retention test strips were tested in comparison to masterlot #286321-80 on internal reference meters.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.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." this event occurred in (b)(6).Occupation was lay user/patient.

Event Description

The initial reporter received questionable results from coaguchek xs meter serial number (b)(4).At 12:26 pm, the meter result was 7.7 inr.At 1:30 pm, the result from a laboratory using an unknown method was 5.7 inr.The therapeutic range was 2.0 - 3.0 inr.

• 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: 9687608
• MDR Text Key: 219783608
• Report Number: 1823260-2020-00372
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 04625315003
• Device Lot Number: 33046111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• 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: 79 YR
• Patient Weight: 65