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

Model Number XS PST

Device Problem Circuit Failure (1089)

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

Event Date 09/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The meter, test strips, and code chip were requested for investigation.

Event Description

We received an allegation that a coaguchek xs meter allowed a patient to test with expired test strips when the date was set correctly and the correct code chip was being used.The patient alleged he tested on (b)(6) 2021 with a result of 2.0 inr on both dates without receiving an error.It was confirmed a result of 2.0 inr on (b)(6) 2021 and 2.0 inr on (b)(6) 2021 were present in the meter memory and the current date on the meter was correct.When attempting to test on (b)(6) 2021 with the same test strips, the patient received an error indicating the test strip had expired.Both results were expected readings and were not questioned.The test strips were lot number 34521321 with an expiration date of 31-mar-2020.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.The customer's returned strips were not tested due to having been expired as of 31-mar-2020.Testing results (qc range = 2.4 3.6 inr): qc 1: 2.9 inr.Qc 2: 2.9 inr.Qc 3: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Evaluation of the meter error log observed error 3 at various times through the day of (b)(6) 2021.Error 3 is triggered when the test strips are expired according to the time/date currently set on the meter.The meter's patient result memory also shows that the strip lot used during those alleged measurements were from lot 49682510 exp.30-apr-2022.The customer's expired strips lot 34521321 exp.31-mar-2020 was not observed as having been used during any of the results within the meter's patient result history.The customer's meter memory does not indicate that results were obtained with expired strips.Medwatch fields d9 and h3 have been updated.

• 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: 12704560
• MDR Text Key: 278623989
• Report Number: 1823260-2021-03138
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 10/27/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2021
• 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: Male