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

Catalog Number 04625358003

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for one patient tested on a coaguchek inrange meter with serial number (b)(4) compared to another coagucheck meter.On (b)(6) 2022, at 10:00 a.M.At the doctor's office, the patient's inr result tested on the coaguchek meter was 3.2 inr.On (b)(6) 2022, at 01:18 p.M., the patient's inr result tested with a coagucheck inrange meter was 2.3 inr.The patient's therapeutic range was 2.5 - 3.0 inr.The serial number of the coaguchek inrange meter was (b)(4).

Manufacturer Narrative

The customer material 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 the results have passed the internal inspection.Initial reporter occupation is patient/consumer.

Manufacturer Narrative

The reporter¿s test strips were provided for investigation and tested with samples collected from marcumar donors on a retention meter in comparison to the master lot of test strips.Testing results: donor 1 hematocrit = 44 %.Donor 2 hematocrit = 37%.Donor 1 results: retention master lot = 2.4 inr returned strips = 2.6.Donor 2 results: retention master lot = 2.0 inr returned strips = 2.2.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16014005
• MDR Text Key: 308452212
• Report Number: 1823260-2022-04096
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625358003
• Device Lot Number: 63311911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• 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: CANDESARTAN 8MG; MARCUMAR
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 55 KG