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 Gastrointestinal Hemorrhage (4476); Melena (4480)

Event Date 06/17/2021

Event Type  Injury  

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.Routine retention testing was performed.Test strip retention samples 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." the medical assessment stated the identified dieulafoy lesion is a large tortuous arteriole most commonly in the submucosal stomach wall, which erodes and bleeds.The presence of anticoagulation makes the risk for bleedings higher.An ulcus dieulafoy is not caused by anticoagulation, but is an independent medical condition.The patient's wife was aware of tarry stools 2 days prior to reporting it to the doctor on (b)(6) 2021.The patient's wife did not mention the tarry stools to the doctor at the time of the 2.3 inr on (b)(6) 2021 and the patient's warfarin dosage was increased by the doctor's advice based on this result which was slightly below therapeutic range of 2.5 - 3.5 inr.Different inr results on different days are generally not comparable.Initial reporter occupation was lay user/patient.

Event Description

There was an allegation the patient was hospitalized for bleeding of the stomach lining while using coaguchek xs meter serial number (b)(4).On (b)(6) 2021 at an unknown time, the result was 2.3 inr.Based on the meter result and the doctor's advice, 1.5 mg of warfarin was added to the normal 3 mg dose for that day.The patient's wife had noticed a darkening of the stool two days before reporting it to the doctor on (b)(6) 2021.The patient had not mentioned the darker stools to the doctor on the (b)(6) 2021 prior to the warfarin adjustment.On (b)(6) 2021, the patient also had symptoms of weakness and issues standing.The patient was taken to the hospital er and then sent to another hospital where blood work was performed.The warfarin was stopped for three days based on a laboratory result of 4.8 inr.The laboratory reagent was not known.On (b)(6) 2021, an endoscopy determined the bleeding was caused by a rare condition called dieulafoy lesions (defined as a vascular abnormality, most commonly in the stomach wall, that erodes and bleeds).During the endoscopy, the bleeding section of the stomach lining was cauterized and clipped.The patient received one unit of blood in the er and two units of blood later in the hospital.The patient's inr results were reported to be "still high" on release from the hospital.The patient's inr result was estimated to be above 4.0 inr but less than 4.8 inr.The patient was advised to withhold warfarin from (b)(6) 2021.The patient began taking 1 mg warfarin on (b)(6) 2021.The therapeutic range was 2.5-3.0 inr and the patient tests weekly.

• 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: 12204138
• MDR Text Key: 268263978
• Report Number: 1823260-2021-02122
• 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: 07/21/2021

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: 05/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 50772321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 77