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

Catalog Number 04625315160

Device Problem Incorrect Measurement (1383)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter's meters and test strips were requested for investigation.The test strips have 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 results have passed the internal inspection.The reporter's meters were provided for investigation where they were tested using retention strips and retention controls.Meter sn (b)(4) testing results (qc range = 4.1 - 6.8 inr): qc 1: 6.0 inr, qc 2: 6.0 inr, qc 3: 6.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The maximum difference between measurements was 0%.Meter sn (b)(4) testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.9 inr, qc 2: 6.1 inr, qc 3: 6.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The maximum difference between measurements was 3%.The alleged results of >8.0 inr and 5.9 inr by the customer (meter serial number (b)(4) ) were not observed in the meter¿s patient result memory.

Event Description

The initial reporter stated they received discrepant results for one patient tested with coaguchek xs meter serial numbers (b)(4).All measurements were performed back-to-back at 10:30 a.M.A first and second measurement were performed with samples collected from the same hand and different fingers of the patient.The patient had a fistula on that arm and came directly from dialysis.It was believed the fistula was packed and flushed with heparin.A first sample collected from the patient was tested using meter serial number (b)(4) resulting in a value of > 8.0 inr.A second sample collected from the patient was tested using meter serial number (b)(4), resulting in a value of 5.9 inr.The third and fourth measurements were performed with samples collected from the patient's other hand and non-fistula arm.A third sample collected from the patient was tested using meter serial number (b)(4), resulting in a value of 3.5 inr.A fourth sample collected from the patient was tested using meter serial number (b)(4), resulting in a value of 3.5 inr.The patient's medication was adjusted based on the 3.5 inr value.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency varies and is at least once every 4 weeks.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12631931
• MDR Text Key: 276397243
• Report Number: 1823260-2021-02983
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2021

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 04625315160
• Device Lot Number: 51508811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/14/2021
• 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: WARFARIN
• Patient Age: 83 YR
• Patient Weight: 76