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

Catalog Number 07671687019

Device Problem Non Reproducible Results (4029)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The meter and test strips were requested for investigation.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.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

We received an allegation of questionable inr result with coaguchek inrange meter serial number (b)(6).At 9:30 am, the meter result using test strip lot 67810018 was 4.3 inr.At 9:35 am, the meter result using test strip lot 70302511 with expiration 31-dec-2024 was 3.0 inr.Customer's therapeutic range was not provided.

Manufacturer Narrative

The reporter's meter and one test strip was provided for investigation where it was tested using retention strips and retention controls.Testing results (customer strip) 2.9 inr.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr.Qc 2: 3.0 inr.Qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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: 19134336
• MDR Text Key: 341458871
• Report Number: 1823260-2024-01197
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K170960
• 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
• Report Date: 04/30/2024

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: 07671687019
• Device Lot Number: 67810018, 70302511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; BISOPROLOL; LOSARTAN; PREGABALIN; WARFARIN
• Patient Age: 77 YR
• Patient Sex: Female