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

Catalog Number 03666794001

Device Problem Off-Label Use (1494)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

We received an allegation of a display issue on a coaguchek xs meter.The date of the event is an approximation; the patient could not specify when the display issue began.The patient alleged the display screen had been fading "for quite some time" and it was hard to read the results.Upon completion of a display check, the segments of the results field were present, however, the patient alleged they have to hold the meter back at an angle to see the "8"s.The meter memory was reviewed and the last result was 2.2 inr.The patient alleged it was "a struggle" to see the result.The patient alleged when he attempted to test on (b)(6) 2023 the display was too light to see.

Manufacturer Narrative

Section e3: occupation is (b)(6).The patient purchases test strips from ebay; he is not sure where he got the meter from.He is not using an independent diagnostic testing facility (idtf).The meter was requested for investigation.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18210768
• MDR Text Key: 329031621
• Report Number: 1823260-2023-03768
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2023

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: 03666794001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/27/2023
• 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
• Patient Sex: Male