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

Catalog Number 04625315160

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

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was alleged that there were discrepant results for one patient tested with coaguchek xs meter serial numbers (b)(4).The patient allegedly had the following results when tested with meter serial number (b)(4) on (b)(6) 2022: > 8.0 inr at 10:59 a.M.1.7 inr at 11:08 a.M.2.4 inr at 11:41 a.M.Within 4 hours of the meter measurements performed on meter serial number (b)(4) on (b)(6) 2022, the patient was reportedly tested with the second meter (serial number (b)(4)) and the result was > 8.0 inr.The patient's therapeutic range is reported to be 2.0 - 3.0 inr.The patient is reportedly tested once or twice a month.

Manufacturer Narrative

The customer's meters and test strips were requested for investigation and replacement product was sent to the customer.The customer's returned meter (serial number (b)(4)) was tested with retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.0 inr, qc 2: 5.1 inr, qc 3: 5.0 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 customer's returned meter (serial number (b)(4)) and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 4.8 inr, qc 2: 4.9 inr, qc 3: 4.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.On review of the meter's patient result memory for meter serial number (b)(4), there was more than one entry of > 8.0 inr, but the time and date settings were set up incorrectly, so it could not be determined if the > 8.0 inr measurement occurred on (b)(6) 2022.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 investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16062769
• MDR Text Key: 308460376
• Report Number: 1823260-2022-04220
• Device Sequence Number: 1
• Product Code: GJS
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625315160
• Device Lot Number: 63311917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/28/2022
• 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: WARFARIN.
• Patient Sex: Male