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

Catalog Number 03666794001

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The customer¿s product was requested for investigation.The product has not been received at this time.If the product is returned in the future, or further information becomes available a follow up report will be submitted.

Event Description

The initial reporter misinterpreted %q results as inr result from coaguchek meter serial number (b)(4).The following results were obtained: on (b)(6) 2020 the result was 15% q (3.3 inr); the customer reported this result as 1.5 inr and their warfarin dose was increased.On (b)(6) 2020 the result was 14% q (3.5 inr); the customer reported this result as 1.4 inr.On (b)(6) 2020 the result was 11% q (4.4 inr); the customer reported this result as 1.1 inr.On (b)(6) 2020 the result was 5% q (8.0 inr); the customer did not report this result.On (b)(6) 2020 the result was 5% q and flagged with a "c" (8.0 inr); the customer did not report this result.The customer's therapeutic range is 2.0- 3.0 inr.The meter did not malfunction.The meter can display results in either %q or inr.The customer interpreted the %q results from the meter with an imagined decimal point in an attempt to interpret the number as an inr result.

• 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: 11021377
• MDR Text Key: 244339880
• Report Number: 1823260-2020-03252
• 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: 12/16/2020

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 Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/16/2020
• 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
• Patient Sequence Number: 1