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

Catalog Number 04625374160

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) compared to a laboratory result using an unknown method.At 7:56 am the meter result was >8.0 inr.At 7:59 am the meter result was >8.0 inr.The laboratory result was 5.3 inr and was obtained within 4 hours of the meter result.The patient's nurse kept the patient's dosage the same (withhold dose for 1 night and resume dose the next day) based on the laboratory result.The patient's therapeutic range is 2.0-3.0 inr.

Manufacturer Narrative

Occupation is patient/consumer.The patient's meter and (1) test strip were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.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." 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13620164
• MDR Text Key: 292727027
• Report Number: 1823260-2022-00537
• 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: 02/28/2022

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: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 53666823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/28/2022
• 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: AMIODARONE; BENADRYL; BONE BUILDER SUPPLEMENTS; BUMETANIDE; CARVEDILOL; EZETIMIBE; FERROUS SULFATE IRON TABLETS; FLOMAX; INHALER FLUTICASONE; LEVOTHYROXINE; LIPITOR; LUPERON DEPOT INJECTION; MUCINEX; NUTRIDYN; PRESERVISION AREDS 2 EYE VITAMIN MINERAL; SPIRONOLACTONE; VITAMIN B3; WARFARIN; XGEVA INJECTION
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 93 KG