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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

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

Event Date 11/19/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer (patient¿s daughter) the coaguchek xs meter serial number was (b)(6).The meter and test strips were requested for investigation.The product has 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.

Event Description

There was an allegation of discrepant inr results with a coaguchek xs meter.The initial result was 4.7 inr.This result was high.The patient retested within 5 minutes using a different finger and the result was 2.6 inr.This result was within the therapeutic range.The patient¿s therapeutic range is 2.0 ¿ 3.0 inr with a testing frequency of monthly.

Manufacturer Narrative

The meter was received for investigation.The test strips were not returned.The returned meter was tested with retention strips and a high-level control sample.Level 1 testing results (qc range = 1.1 - 1.4 inr): qc 1: 1.3 inr.Level 2 testing results (qc range = 2.4 ¿ 3.6 inr): qc 2: 2.9 inr.The obtained results were in the allowed range.No error messages occurred during the investigation.The returned material and the retention material meet the specifications.The alleged result of 4.7 inr was observed in the meter's patient result memory.The alleged result of 2.6 inr was not observed in the meter's patient result memory.A result of 2.8 inr was observed in the meter's patient result memory with a different date.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18326293
• MDR Text Key: 330496509
• Report Number: 1823260-2023-03987
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 66283721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/09/2024
• 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: DILTIAZEM; EZETIMIBE; LASIX; PHENOBARBITAL; POTASSIUM; WARFARIN
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 113 KG