MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PROF KIT; PROTHROMBIN TIME MONITOR

Catalog Number 3666794001

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.

Event Description

The initial reporter had an issue with the coaguchek xs meter that could lead to a misinterpretation of results.The customer stated she would insert a strip but the code would not appear on the screen.The customer stated she had used current strip a couple of times.The customer inserted a new strip into the meter with meter powered on.The meter beeped, but no code came up on the screen.The customer powered the meter off and on.A display check was performed and was acceptable.The customer inserted a strip and heard a beep, but no code appeared on the screen.The customer turned off the meter and inserted a strip, then the customer powered on the meter, but no code appeared on the screen.The customer used a second bottle of strips, inserted code key, and inserted a new strip.No code appeared on the screen, but a beep was heard.The customer checked the meter memory and confirmed the last test result was present.There were no missing or faded segments.

Manufacturer Narrative

The reporter's meter was returned for investigation.The display was confirmed to be functioning as expected.Visual inspection showed the test strip adapter is out of alignment due to bent pins.The damaged pins are due to a handling error, likely due to being dropped.Due to the incorrect positioning of the adapter, the test strip is recognized as "invalid strip type" (e 151).Due to this error, the measurement is not continued and the code key is not read and displayed.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS PROF KIT
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10445683
• MDR Text Key: 204225240
• Report Number: 1823260-2020-02089
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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: Health Professional
• Device Catalogue Number: 3666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1