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

Catalog Number 03666794001

Device Problem Circuit Failure (1089)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's meter was returned for investigation.Replacement product was sent.The investigation observed that the meter failed to power on with fresh retention batteries.The investigation is ongoing.Initial reporter occupation is patient/consumer.

Event Description

There was an allegation of a display issue with a coaguchek xs meter.The reporter stated the meter's batteries have been replaced three times within the last three weeks.The time and date had to be set each time the batteries were replaced.The reporter attempted to run a test, and an error 5 appeared in the center of the meter's display.The reporter stated on the top of the 5, there were three dashes and then a dash on the left side and right side of the 5.The reporter confirmed the bell was flashing in the top right corner of the display.The reporter performed a display check and confirmed there were no missing segments.The reporter entered the meter's memory and had no issues with the last test result of 2.5 inr on (b)(6) 2021.The reporter confirmed the battery well is clean, dry, and not corroded.Also, the reporter confirmed the test strip guide was clean.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12771554
• MDR Text Key: 280525080
• Report Number: 1823260-2021-03260
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• 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: Female