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 Problems Transient Ischemic Attack (2109); Insufficient Information (4580)

Event Date 03/10/2022

Event Type  Injury  

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: 5.3 inr.Qc 2: 5.3 inr.Qc 3: 5.4 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) since (b)(6) 2021 and a report of the patient being hospitalized.On (b)(6) 2022, the result from the meter was reported to be 1.3 inr.The warfarin dose was reportedly increased by an unknown amount.On (b)(6) 2022 at 2:05 pm, the result from the meter was reported to be 1.5 inr.The warfarin dose was reportedly increased by an unknown amount.On (b)(6) 2022 at 1:17 pm, the result from the meter was reported to be 2.7 inr.On possibly (b)(6) 2022, the patient went to the hospital allegedly due to stroke-like symptoms such as stuttering and trouble speaking.The patient was reportedly admitted to the hospital for three days and an mri was performed that did not show a stroke.The patient's inr was taken upon admission to the hospital and was reported to be 7.0 inr.The patient's warfarin dose was allegedly withheld that night and the next morning.The next morning, in the hospital, the patient's inr was reported to be 2.5 inr.No further information regarding the treatment received could be provided.It was reported that the doctors never determined the cause of her stroke-like symptoms.The therapeutic range was 2.0-3.0 inr and the patient tests weekly.This mdr is being submitted in an abundance of caution.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14242393
• MDR Text Key: 290457892
• Report Number: 1823260-2022-01216
• 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: 04/28/2022

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: 07/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 52333121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/28/2022
• 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: CARBIDOPA; ENALAPRIL; FLUOXETINE; IMDUR; METOPROLOL; OXYBUTIN; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 86 KG