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 Stroke/CVA (1770)

Event Date 01/13/2022

Event Type  Injury  

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4).While troubleshooting, the reporter (the patient's daughter) mentioned a previous stroke event for the patient.On (b)(6) 2022, the patient allegedly tried to help someone lift a tv into the car, and afterward, the patient's daughter noticed all the capillaries in his temple were purple.At that time, the patient was reportedly taking 30-35 mg/week of warfarin.On (b)(6) 2022, the patient tested as usual and the result reported to be from the meter was 4.4 inr.The patient reportedly lowered their dose of warfarin to 2 mg instead of 4 mg that day and he ate a piece of lettuce.On (b)(6) 2022 at an unknown time, the patient allegedly retested with a result of 2.9 inr.The patient allegedly went to dinner that night and felt like he lost vision.The patient daughter allegedly suspected he was having a stroke, so they went home and tested with the meter.Around 8 pm, the result reported to be from the meter was 2.6 inr.The reporter allegedly called 911 and was taken by ambulance to the hospital.The result at an unknown time from the hospital laboratory using an unknown reagent was reported to be 2.2 inr.While he was hospitalized, the reporter allegedly compared the meter results to the laboratory results, and sometimes the meter was 0.4 inr or 0.5 inr different from the laboratory.Specific results were requested but could not be provided.The patient was allegedly put on heparin, but they allegedly could not keep him in the therapeutic range.The patient was reportedly given ct scans and they allegedly saw that the patient had multiple tias in the past.The patient was allegedly anemic around that time and was given ferrous sulfate while in the hospital.The patient has reportedly not been anemic since then.The patient allegedly lost some of his vision after the stroke in (b)(6) 2022.The therapeutic range at the time of the event was 3.0-3.7 inr.After the event, his therapeutic range was reportedly increased to 4.0-4.7 inr.The patient reportedly tests as often as necessary to stay in range, at least weekly.The patient was reported to be stable.This mdr is being submitted with an abundance of caution.

Manufacturer Narrative

The meter and strips have been requested for return.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." initial reporter occupation was patient/consumer.

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: 4.9 inr, qc 2: 5.0 inr, qc 3: 5.0 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.

• 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: 15771127
• MDR Text Key: 303418918
• Report Number: 1823260-2022-03577
• 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,Followup
• Report Date: 12/08/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 12/08/2022
• 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: ATORVASTATIN.; BABY ASPIRIN.; LISINOPRIL.; METOPROLOL.; SERTRALINE.; VITAMIN C SUPPLEMENT.; WARFARIN.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 49 KG