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

Model Number N

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 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.The returned test strips were measured 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.Marcumar donor 1 hematocrit = 44 %; marcumar donor 2 hematocrit = 37 %.Testing results: marcumar donor 1 with master lot strips = 2.4 inr; marcumar donor 1 with returned strips = 2.5 inr; marcumar donor 2 with master lot strips = 2.0 inr; marcumar donor 2 with returned strips = 2.0 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.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.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." upon review of the meter's patient result memory, the following were the only values listed for (b)(6) 2022: 2.4 inr at 06:13 on (b)(6) 2022; 2.2 inr at 06:15 on (b)(6) 2022.

Event Description

It was alleged that a patient received questionable results when testing with coaguchek xs meter serial number (b)(4).It was alleged that the patient performed back-to-back tests on the meter at 7:30 a.M.On (b)(6) 2022, resulting in values of 2.4 inr and 2.0 inr respectively.It was reported that at 17:00 on the same day, a sample from the patient was tested on the meter, resulting in a value of 2.1 inr.It was alleged that at 10:00 a.M.On (b)(6) 2022, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 1.9 inr.The patient is reported to have a therapeutic range of 2.0 - 3.0 inr.The patient reportedly measures with the meter 1-2 times a month.

Manufacturer Narrative

The component, evaluation method, evaluation result, and evaluation conclusion codes have been updated.

• 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: 16022883
• MDR Text Key: 308392384
• Report Number: 1823260-2022-04133
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: N
• Device Catalogue Number: 04625315016
• Device Lot Number: 55343013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• 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: GABAPENTIN; HEPARIN; L-THYROXINE; MARCUMAR
• Patient Age: 47 YR
• Patient Sex: Female