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

Catalog Number 04625374160

Device Problem Incorrect Measurement (1383)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.Unique device identifier (udi) (b)(4).The customer¿s test strips and meter were requested for return.The product has not been received at this time and is not expected to be returned.If the product is returned in the future, a follow-up report will be submitted.Routine retention testing was performed.Test strip retention samples passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation of questionable inr results with a coaguchek xs meter serial number (b)(4) compared to her doctor's coaguchek xs meter.A new finger was used for each meter test.The first drop of blood was wiped away for testing on the doctor's coaguchek xs meter.At 16:44, the patient's inr result on the patient's coaguchek xs meter was 7.0 inr.At 17:20, the patient's inr result on the doctor's coaguchek xs meter was 3.6 inr.The inr result from the doctor's coaguchek xs meter was determined to be correct.The patient's therapeutic range is 2.0- 3.0 inr.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 11947128
• MDR Text Key: 254527607
• Report Number: 1823260-2021-01671
• 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: 06/07/2021

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 50772022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/07/2021
• 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
• Treatment: ATORVASTATIN; FISH OIL; FUROSEMIDE; POTASSIUM; VITAMIN D3; WARFARIN
• Patient Age: 72 YR
• Patient Weight: 73