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

Catalog Number 04625374160

Device Problems High Test Results (2457); High Readings (2459)

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

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation.Replacement product was sent.The product has not been received at this time and is not expected to be returned.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.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods." occupation is patient/consumer.

Event Description

There was a complaint of questionable inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The result from the meter at 09:52 was 4.6 inr.The result from the meter at 10:04 was 4.7 inr.The result from the laboratory at 11:54 was 3.3 inr.This result was believed to be correct and the patient's warfarin dose was slightly decreased.The patient¿s therapeutic range is 2.0-3.0 inr.

Manufacturer Narrative

The patient¿s test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr qc 2: 3.0 inr qc 3: 3.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d9 and h3 have been updated.

• 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: 13568351
• MDR Text Key: 292581813
• Report Number: 1823260-2022-00455
• 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: K062925
• 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: 03/18/2022

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: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54145321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/19/2022
• 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
• Treatment: BARIATRIC FUSION MULTI VITAMIN GUMMIES; LEVOTHYROXINE; SPRING VALLEY VITAMIN B1; SPRING VALLEY VITAMIN B12; VITAMIN D3; WARFARIN
• Patient Age: 47 YR
• Patient Sex: Female