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 Hemorrhagic Stroke (4417)

Event Date 05/01/2022

Event Type  Injury  

Event Description

The initial reporter (customer's husband) alleged concerns with high results from coaguchek xs meter serial number (b)(4).While troubleshooting, the reporter mentioned a previous hospitalization for the patient.The date was set incorrectly on the meter.The reporter provided the following results leading up to the event from the customer's log: on (b)(6) 2022, the result was reported to be 1.6 inr.The warfarin dose was allegedly increased but the dosage amount could not be provided.On (b)(6) 2022, the result reported to be from the meter was 1.8 inr.On (b)(6) 2022, the result from the meter was reported to be 2.2 inr.On (b)(6) 2022, the result from the meter was reported to be 2.4 inr.The patient allegedly had an extremely high inr reading in may, went to the er, and was hospitalized.The specific date of the event could not be provided.The reporter did not know the specific laboratory inr result on the day of the event.However, he allegedly was told it was 15x what it was supposed to be.The patient had a ct scan and mri and allegedly had a brain bleed.The reporter did not know what treatment the patient was given.He alleged the patient was given something to lower the inr, but did not know what it was.The reporter did not know if she was taken off warfarin.The reporter could not provide any inr results from the time the patient was hospitalized.The patient was allegedly hospitalized until (b)(6) 2022 and was then taken to a nursing home.The patient was released to go home on (b)(6) 2022.The patient's current condition was reported to be normal but somewhat confused.The therapeutic range was 2.5-3 inr and the patient tests once a week.

Manufacturer Narrative

The meter and strips have been requested for return.The strips from the event were not available.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.A replacement meter was provided to the customer.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.

Manufacturer Narrative

The reporter's meter and one test strip 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 the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's alleged results of: 1.6 inr on (b)(6) 2022.1.8 inr on (b)(6) 2022.2.2 inr on (b)(6) 2022.2.4 inr on (b)(6) 2022.Were not observed in the meter's patient result memory.All other customer alleged results were observed in the meter's patient result memory but the time/date was not set correctly.

• 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: 15169648
• MDR Text Key: 297312495
• Report Number: 1823260-2022-02292
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 56561322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• 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: WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 48 KG