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

Catalog Number 07671687003

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The returned test strips were measured with the returned meter in comparison with the current test strip master lot.For this purpose, two human blood samples from marcumar donors and internal reference meters were used.Test 1: 2.5 inr.Test 2: 2.1inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.The returned customer material and retention material comply with the specification.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.Occupation was patient/consumer.

Event Description

There was an allegation of questionable results from coaguchek inrange meter serial number (b)(4).At 09:20, the result from the meter was 4.3 inr.At 09:30, the result from a laboratory using recombiplastin reagent was 2.88 inr.At 09:40, the result from an inrange meter at the doctor's laboratory was 3.1 inr.The therapeutic range was 2-3 inr and the patient tests once a week.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16009462
• MDR Text Key: 308414381
• Report Number: 1823260-2022-04093
• 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
• Report Date: 12/19/2022

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: 04/30/2024
• Device Catalogue Number: 07671687003
• Device Lot Number: 65779312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• 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: ANLODIPIN.; ATROVASATIN.; MARCUMAR.; VALSATAN.
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 126 KG