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

Catalog Number 04625358016

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The country of origin is (b)(6).The customer¿s product was requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Relevant retention test strips (lot 334498) were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4).The meter result was 5.9 inr and a few minutes later the meter result was 2.9 inr.The patients therapeutic range is 2.5-3.5 inr.

Manufacturer Narrative

The customer's meter and strips were returned for investigation.The returned product was measured with a retention meter in comparison to a retention meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.8 inr, donor 2 inr: 2.8 inr.; donor 1 hct: 48%, donor 2 hct: 48%.; testing results: donor #1: retention meter and master lot strips: 2.8 inr , customer meter and customer strips: 2.7 inr.; donor #2: retention meter and master lot strips: 2.8 inr, customer meter and customer strips: 2.9 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.Medwatch fields concomitant medical products and device evaluated by mfr have been updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9181558
• MDR Text Key: 217463894
• Report Number: 1823260-2019-03675
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358016
• Device Lot Number: 33449818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Treatment: MOXICILLINA; SINTRON
• Patient Age: 8 YR