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

Catalog Number	07797826160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's meter and test strips were requested for investigation and replacement product was sent to the customer.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.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." occupation - the occupation is patient/consumer.
Event or Problem Description
It was reported that a patient received a discrepant result when testing with coaguchek xs meter serial number (b)(4).At 18:31, the patient had a meter result of 4.9 inr.The patient then went to the emergency room.At around 8 p.M., a sample from the patient was tested in the laboratory at the emergency room using an unknown method, resulting in a value of 3.3 inr.The patient's therapeutic range is 1.5 - 2.5 inr.The patient's testing interval is every 2 - 3 weeks.
Additional Manufacturer Narrative
The patient was taking antibiotics at the time of the event.Per product labeling: "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).Additional medication should only be taken if prescribed by the treating physician.If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted as directed by the treating physician.".

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• 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: 15563104
• Report Number: 1823260-2022-03084
• Device Sequence Number: 6575584
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 07797826160
• Device Lot Number: 58078513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTIC.; BABY ASPIRIN.; BLOOD PRESSURE MEDICATION.; FLOMAX.; WARFARIN.
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG