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

Catalog Number 04625315003

Device Problem Non Reproducible Results (4029)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer the coaguchek xs meter serial number was (b)(6).The product was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.

Event Description

We received an allegation of discrepant inr results on a coaguchek xs meter.The result at 12:00 was 1.8 inr.The result at 12:10 was 2.6 inr.The result at 12:20 was 3.5 inr.The patient¿s therapeutic range is 2.0 ¿ 3.0 inr.

Manufacturer Narrative

The meter was returned for investigation and tested with retention strips and controls.Testing results (qc range = 2.3 ¿ 3.5 inr): qc 1: 2.9 inr qc 1: 2.8 inr qc 1: 2.8 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.The patient's alleged results were not observed in the meter's patient result memory.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

No product was received for investigation.As the product was not returned, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK XS PT TEST
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18741973
• MDR Text Key: 335812083
• Report Number: 1823260-2024-00492
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625315003
• Device Lot Number: 72703815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• 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