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

Catalog Number 04625374160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The meter and test strips were requested for investigation.The meter and test strips were provided for investigation.An e-62 error message was observed on the returned meter.This error is related to a temperature or heater error.The returned test strips were tested with a retention meter and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 3.0 inr, qc 2: 2.9 inr, qc 3: 2.9 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 alleged result of 2.7 inr on (b)(6) 2023 was not observed in the meter¿s patient result memory.The alleged result of 2.6 inr on 14-oct-2023 was not observed in the meter¿s patient result memory.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." the investigation is ongoing.

Event Description

There was an allegation of discrepant inr results with a coaguchek vantus meter compared to an unknown laboratory method.On 14-oct-2023 the result from the meter was reportedly 2.6 inr.The result from an unknown laboratory method within 4 hours was reportedly 1.6 inr.On (b)(6) 2023 the result from the meter was 1.7 inr.The result from an unknown laboratory method within 4 hours was reportedly "in the low 2.0¿s inr." the specific result was not provided.On (b)(6) 2023 the result from the meter was 1.7 inr.The result from an unknown laboratory method within 4 hours was reportedly "in the low 2.0¿s inr." the specific result was not provided.On (b)(6) 2023 the result from the meter was reportedly 2.7 inr.The result from an unknown laboratory method within 4 hours was reportedly "in the low 2.0¿s inr." the specific result was not provided.The patient¿s therapeutic range is reportedly 2.0 ¿ 3.0 inr with an alleged testing frequency of twice a month.

Manufacturer Narrative

The meter was investigated further due to the e-62 error message.The circuit board and heater were checked for contamination or damage.The investigation identified a defective heating coil.The returned test strips worked as specified.The e-62 error message was due to the defective heating coil.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18187977
• MDR Text Key: 328984450
• Report Number: 1823260-2023-03742
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 65031624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN; ATORVASTATIN; BABY ASPIRIN; GLUCOSAMINE CHONDROITIN; LOSARTAN; SR MULTIPLE VITAMIN; WARFARIN
• Patient Age: 68 YR
• Patient Sex: Male