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

Catalog Number 04625374160

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 06/17/2022

Event Type  Injury  

Event Description

There was an allegation of questionable high results from coaguchek xs meter serial number (b)(4) that reportedly led to the patient having a suspected but unconfirmed tia (transient ischaemic attack).On (b)(6) 2022, the result reported to be from the meter was 4.1 inr.The patient's healthcare provider allegedly thought this was too high and decreased the warfarin dose.The patient was allegedly told to take 7.5 mg all days leading up to (b)(6) 2022 when she resumed taking 10 mg.Reportedly, the customer¿s normal warfarin dose is 10 mg m/w/f and 7.5 mg on the other days of the week.On (b)(6) 2022 at 7:00 am, the result reported to be from the meter memory was 3.6 inr.On (b)(6) 2022 at 05:30 pm, the patient went to the hospital.The result from the hospital laboratory using an unknown reagent taken at 7:00 pm was reported to be 2.2 inr.The patient allegedly went to the hospital due to not being able to see, "seeing colors", and reportedly being very weak and having diarrhea.Allegedly, the hospital thought it was an acute migraine attack but as they were not sure, they allegedly treated the patient as having a tia.Reportedly, no damage was found in the brain from testing and imaging.Reportedly, the patent had a cat scan (plain, no contrast), bloodwork, and an ekg.The patient alleged they thought it was cardiac in nature (blood clot slipped through) but it did not "land anywhere" and just dissipated.Allegedly, the patient had a follow-up mri and it showed everything was okay and there was no damage.The patient reportedly had an additional cat scan to review the small blood vessels, but the results were not available.On (b)(6) 2022, the result reported to be from the meter was 2.6 inr.On (b)(6) 2022, the result reported to be from the meter was 3.1 inr.On (b)(6) 2022, the result reported to be from the laboratory using an unknown method at 9:30 am was 3.2 inr.The result reported to be from the meter at 10:00 am was 4.2 inr.The therapeutic range was 2.5-3.5 inr.

Manufacturer Narrative

The reporter's meter 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: 5.2 inr; qc 2: 5.2 inr; qc 3: 5.1 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.However, the date and time were not set correctly.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 was patient/consumer.

• 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: 15302778
• MDR Text Key: 298702773
• Report Number: 1823260-2022-02584
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 58526221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/26/2022
• 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: BABY ASPIRIN; JANTOVEN; LOVENOX; METOPROLOL; NURTEC; REPATHA; SYNTHROID; WARFARIN; XANAX
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG