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 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.Replacement product was sent.The patient's meter was provided for investigation where it was tested using retention strips and retention controls.(b)(6).The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The obtained qc values were observed in the meter memory without issues or defects.No memory issues were observed.The patient's alleged result of 2.6 inr on (b)(6) 2021 was not observed within the meter's patient result memory.However, a result of 2.1 inr / 26 %q was observed on (b)(6) 2021.The patient's alleged result of 2.4 inr was not observed within the meter's patient result memory until (b)(6) 2020, which was beyond the patient's time frame of "a couple of weeks ago." the investigation did not identify a product problem.The cause of the event could not be determined.Initial reporter occupation: occupation is patient/consumer.

Event Description

There was an allegation of a coaguchek xs meter memory issue.The patient reported that the set and date were flashing.The patient set the time and date on the meter.The patient noticed the meter's unit was in %q and not in inr.The patient stated the last displayed meter result from "last week or a couple weeks ago" was 2.4 and with a unit of inr.On (b)(6) 2021, the patient performed a test on the meter and received a result of 2.9 inr.The patient checked the meter's memory and there was not a 2.4 inr result.The patient confirmed the inr result on (b)(6) 2021 was 2.6 inr instead of 2.4 inr.The meter's memory displayed the inr result of 2.1 inr on (b)(6) 2021.The customer advised the result of 2.1 inr was never received on (b)(6) 2021.

• 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: 12793571
• MDR Text Key: 285002769
• Report Number: 1823260-2021-03327
• 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
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 11/05/2021
• Date Manufacturer Received: 10/21/2021
• 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