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

Model Number XS PST

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

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.Occupation was lay user/patient.

Event Description

The initial reporter alleged the coaguchek xs meter allowed her to test with expired strips when the date was set correctly and the correct code chip was used.The customer alleged a test was completed on (b)(6) 2020 and a result of 1.6 inr was received without error.The strips used were lot 29415123 with an expiration date of 31-jul-2019.It was confirmed a result of 1.6 inr was present in the meter memory with a date of (b)(6) 2020 and the current date on the meter was correct.When attempting to test on (b)(6) 2020 with the same test strips, the customer received an error indicating the test strip has expired.The result received on (b)(6) 2020 was believed to be correct and was not questioned.

Manufacturer Narrative

Medwatch fields h3 and d10 were updated.The reporter's meter was returned for investigation.Based on the error report in the meter's memory, several errors indicated that expired strips were in use.When checking the meter's patient result memory, the 1.6 inr value on 11-mar-2020 was observed.However ,the test strip lot in use with this measurement was 417474.There were no results successfully obtained with the strip lot (294151-23) in question.When the customer was using lot 294151 on 12-mar-2020 and 16-mar-2020, the error report in the meter's memory displayed an error indicating that the strips in use were expired.The meter worked as specified when the lot was used after expiration.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9920326
• MDR Text Key: 220895398
• Report Number: 1823260-2020-00939
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1