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

Catalog Number 04625374160

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer.The strips were requested for investigation, however, there are no test strips remaining to return.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

We received an allegation of questionable inr results for 1 patient tested with coaguchek vantus meter serial number (b)(4) compared to an unknown laboratory method.On (b)(6) 2022 the patient had a meter result of 4.7 inr while the laboratory result was 3.6 inr.The time difference between the measurements was around 45 minutes.The patient thought that his finger was dry before testing but he wasn't sure about it and he didn't think he was dosing the strip within 15 seconds of poking his finger.The patient also mentioned that he squeezed the finger to get the blood drop and he was advised against excessive squeezing.The patient's therapeutic range was 2.5-3.5 inr and the interval of testing is once every 1-2 weeks.The patient did not know the lot number of the test strips that was used on (b)(6) 2022 and there wasn't any product left to return.

Manufacturer Narrative

The patient didn´t apply the blood sample within 15 sec.For a valid result the drop of blood has to be applied to the test strip within 15 sec.Otherwise the coagulation has already started in the sample on the pricked finger.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16419216
• MDR Text Key: 310056108
• Report Number: 1823260-2023-00535
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/10/2023
• 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
• Treatment: WARFARIN
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 91 KG