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

Catalog Number 04625374160

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

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(6).At 1:11 pm, the meter result using test strip lot 62216021 with expiration date 31-dec-2023 was 1.6 inr.At 1:50 pm, the meter result using test strip lot 64708121 was 2.6 inr.Customer's therapeutic range is 2.0-3.0 inr.The customer states their results are usually between 2.2 -2.6 inr.The customer tests every two weeks.

Manufacturer Narrative

E3-occupation is patient/consumer.The meter and test strips were requested for investigation.The meter has been returned for investigation.The investigation is ongoing.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.

Manufacturer Narrative

The returned meter was measured with the retention test strip lots 64708110 and 62216010 in comparison to the current test strip master lot.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Donor 1 hct: 45% donor 2 hct: 45% testing results: donor #1: retention meter and master lot strips: 2.9 inr returned meter and retention strips (lot 62216010): 2.8 inr.Returned meter and retention strips (lot 64708110): 2.8 inr.Donor #2: retention meter and master lot strips: 3.1 inr.Returned meter and retention strips (lot 62216010): 3.1 inr.Returned meter and retention strips (lot 64708110): 3.0 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.Returned customer material and retention material complies with specification.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 16955580
• MDR Text Key: 316435270
• Report Number: 1823260-2023-01672
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 64708121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2023
• 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: CILOSTAZOL.; COQ10.; FARXIGA.; METOPROLOL.; OMEPRAZOLE.; OZEMPIC.; PEPCID.; PLAVIX.; ROSUVASTATIN.; TADALAFIL.; VITAMIN B12.; VITAMIN C.; VITAMIN D3.; WARFARIN.; ZINC.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG