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

Model Number XS PST

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The occupation is lay user/patient.

Event Description

The initial reporter stated he has had multiple issues with coaguchek xs meter serial number (b)(4).The issues include a missing result in the meter's patient result memory, errors, incorrect units of measure, and the a.M./p.M.Time designation on the meter is "opposite of what it should be".In addition to these issues, the reporter stated he received a discrepant result when testing with the meter and an unknown test strip lot number.This medwatch will apply to the meter.Please refer to the medwatch with patient identifier (b)(6) for information related to the test strips.The patient's therapeutic range is 2.0 - 2.9 inr.The patient's testing frequency is one to two times per week.

• 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: 10023948
• MDR Text Key: 216136206
• Report Number: 1823260-2020-01173
• Device Sequence Number: 1
• Product Code: GJS
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 03666794001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 88