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

Catalog Number 04625374160

Device Problems Circuit Failure (1089); Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/31/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.The reporter's meter and one test strip were provided for investigation where they were tested using a retention control.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 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 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.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.".

Event Description

It was alleged that a patient received a questionable test result when testing with coaguchek xs meter serial number (b)(4).When testing with the meter at 9:30 a.M.On (b)(6) 2022, the patient received a result of 1.9 inr.Within 4 hours of the meter test, the patient allegedly received a laboratory value of 2.5 inr when tested with an unknown method.It was reported that decisions were made based on the laboratory value instead of the meter value.The patient's therapeutic range is reported to be "around 2.6 inr".The patient's testing frequency is reported to be every 2 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16280762
• MDR Text Key: 308916512
• Report Number: 1823260-2023-00315
• 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
• Report Date: 02/01/2023

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 02/01/2023
• 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: ADVAIR; ALBUTEROL; BABY ASPIRIN; EZETIMIBE; IPRATROPIUM; IRON; ISOSORBIDE; LOSARTAN; MONTELUKAST; PANTOPRAZOLE; ROSUVASTATIN; WARFARIN
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 84 KG