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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was alleged that a patient measured discrepant values on coaguchek xs professional meter serial number (b)(4) when compared to laboratory tests performed with an unknown method.The patient's therapeutic target was reported as 2.0 inr.The patient allegedly had a meter result of 6.4 inr on (b)(6) 2022.Based on the high meter result, the patient allegedly had his inr checked at a laboratory and the value was 10.2 inr, reportedly within 4 hours of the meter testing.The patient was allegedly sent to the hospital on (b)(6) 2022 based on the provider's laboratory inr result.The patient was allegedly re-checked at the hospital and the patient received vitamin k on (b)(6) 2022 based on the inr result received.On (b)(6) 2022, the patient allegedly had a meter result of 1.3 inr.Reportedly, within 4 hours of meter testing, the patient had a laboratory test, resulting in a value of 2.1 inr.It was reported that the patient's coumadin had been withheld.

Manufacturer Narrative

The customer's meter and test strips were requested for investigation and replacement product was sent to the customer.The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 5.1 inr.Qc 2: 5.0 inr.Qc 3: 4.9 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 customer had alleged receiving 6.4 inr on (b)(6) 2022, however, upon review of the meter's patient results memory, a result of 6.9 inr was observed on (b)(6) 2022.The meter's patient results memory also did not show a value of 2.5 inr on (b)(6) 2022.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.

Manufacturer Narrative

The patient and health effect - impact codes have been updated.

• 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: 15439650
• MDR Text Key: 300455726
• Report Number: 1823260-2022-02852
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 04625315160
• Device Lot Number: 58526211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/19/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 140 KG