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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problems Vomiting (2144); Dizziness (2194); Ischemia Stroke (4418)

Event Date 04/18/2022

Event Type  Injury  

Event Description

On 10-jun-2022, we received an allegation of questionable inr results for one patient tested with a coaguchek xs serial number (b)(4) compared to a laboratory stago max compact analyzer with neoplastin reagent.Reportedly the patient had a blood clot and received treatment on (b)(6) 2022.There were two test strip lot numbers reported, but it is unknown which results were generated from each lot number.Test strip lot number 54974524 had an expiration date of 31-jan-2023.Test strip lot number 57260821 had an expiration date of 31-may-2023.On (b)(6) 2022, the patient's meter result was 3.2 inr.On (b)(6) 2022, the patient allegedly felt dizzy and vomited and went to the emergency room.Reportedly the patient's inr result at the hospital was 2.9 inr.Based on the laboratory inr result, allegedly the patient's warfarin dosage was changed.It was reported the patient had a computerized axial tomography (cat) scan and a magnetic resonance imaging (mri) scan to determine if he had a blood clot.Allegedly the patient's doctor stated the blood clot was on the way to the brain but the specific location was unknown.Reportedly the patient was provided "fluids" but the specific treatment was unknown.It was reported the blood clot dissolved.Allegedly the patient was in the hospital overnight for observation and discharged on (b)(6) 2022.Prior to the event, the patient¿s dosage was determined from the meter inr results.Following the event, it was reported the patient¿s dosage was determined from the laboratory inr results.After the event, the patient had the following meter-to-lab comparison results: (b)(6).The patient's testing frequency is weekly.The patient's current condition was reportedly normal.

Manufacturer Narrative

The test strips and meter were requested for an investigation, however, the test strips are not available for return.Replacement product was sent.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." occupation is patient's wife/consumer.

• 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: 14956581
• MDR Text Key: 295491323
• Report Number: 1823260-2022-02000
• 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: 07/08/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 54974524, 57260821
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/08/2022
• 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: "DILTIZEM HCL"; ASPIRIN; ATORVASTATIN; FUROSEMIDE; LOSARTAN POTASSIUM; METOPROLOL; WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 108 KG