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

Catalog Number 04625374160

Device Problem Battery Problem (2885)

Patient Problems Hemorrhagic Stroke (4417); Insufficient Information (4580)

Event Date 12/16/2022

Event Type  Injury  

Event Description

We received an allegation that the coaguchek vantus (usa) meter with serial number (b)(4) may have contributed to the patient's "little bleeding on the brain".On (b)(6) 2023, the reporter initially called because they were out of test strips.During the call, the reporter stated that on (b)(6) 2022, the patient allegedly fell and "stood up crooked".The reporter stated that he called 911 and the paramedics picked the patient up and took her to the hospital.The reporter stated that the patient was in this hospital for 3-6 hours.The reporter stated that he does not know if they tested the patient's inr while she was in that hospital.They reportedly did "some sort of scan" and found a "little bleeding on the brain".The patient's blood sugar was also reportedly a little high.They then reportedly life-flew the patient to another hospital.The laboratory inr result using an unknown method was reportedly "9 something".The patient was reportedly given a heparin drip line.The patient was also reportedly given unknown antibiotics for a urinary tract infection (uti).The reporter stated that he was not aware of any other treatment that the patient was given while hospitalized.The reporter stated they could not do a magnetic resonance imaging (mri) to check for a stroke because she has a linq loop recorder in her chest.The reporter stated the recorder could have a wire in it that is sensitive to the mri machine.The reporter stated that the patient was not given any other treatment that he is aware of.The reporter stated they changed her warfarin from 5 mg to 4.5 mg on (b)(6) 2023.The reporter stated that the patient was released from that hospital on (b)(6) 2023.The reporter stated that the patient will be starting occupational and physical therapy soon.The reporter stated that the patient's test strips could have been stored in a "90-degree" room.The therapeutic range is reportedly 2.5-3.0 inr.Meter results related to the event were requested but not provided.During the call, an attempt was made to check the meter memory but the meter would not turn on and the reporter did not have new batteries to insert.This mdr is being submitted with an abundance of caution.

Manufacturer Narrative

The reporter stated that they do not have the test strips the patient was using before the hospital visit.The meter was requested for investigation and 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 the results have passed the internal inspection.  the reporter stated that the patient's test strips could have been stored in a 90-degree room.Product labeling states "you can store test strips at room temperature or in the refrigerator (2-30 °c or 36 °f).Occupation: patient/consumer the reporter is the patient's grandson.

• 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: 16288134
• MDR Text Key: 308702314
• Report Number: 1823260-2023-00330
• 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: K170960
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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?: No
• Date Manufacturer Received: 01/04/2023
• 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: LEVOTHYROXINE.; METFORMIN,; METOPROLOL,; WARFARIN,
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG