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

Catalog Number 04625374160

Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

We received an allegation of the printed code number on code key did not match the code that appeared on the coaguchek xs meter when the patient inserted the strips.Although the patient verified that the strip's code key had 107 printed on it, yet when the code key of 107 was inserted into the meter, the patient saw a code of 100.The patient then inserted a different strip with the code key of 107 and saw the code of 107 on the meter.On (b)(6) 2023 at 7:43 a.M.The patient had a meter result of 4.3 inr.The patient's therapeutic range was 2.0-3.0 inr.The coaguchek xs meter was with a serial number of (b)(6).

Manufacturer Narrative

The code key/chip was requested for investigation.Investigation is ongoing.

Manufacturer Narrative

Device code (a code) was updated.No material is expected to be provided for investigation since the problem was already locally solved during the call.The mentioned problem was not reported from other patients.The code chip of the corresponding retention material has s_107 printed on it.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 16916069
• MDR Text Key: 315092369
• Report Number: 1823260-2023-01603
• 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: 07/03/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 64708121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 07/03/2023
• 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