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

Catalog Number 04625374160

Device Problems Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/27/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results with a coaguchek xs meter compared to an unknown laboratory method.On (b)(6) 2023 the result from the meter was reportedly 3.4 inr.On (b)(6) 2023 the result an unknown time later from an unknown laboratory method was reportedly 5.4 inr.The patient¿s therapeutic range is reportedly 2.5 ¿ 3.5 inr.

Manufacturer Narrative

Section e3: occupation is the patient's daughter.The medical opinion by a roche physician concluded that the information provided does not reasonably suggest the device contributed to the patient's hospitalization for tia or stroke.The patient¿s inr prior to both the tia and the stroke were therapeutic and no dosing changes were made prior to the event.Furthermore, there is a significantly increased short term risk of an ischemic stroke after a tia with an incidence of 2 to 17% (hill md, coutts sb.Preventing stroke after transient ischemic attack.Cmaj.2011;183(10):1127-1128.Doi:10.1503/cmaj.110704).On (b)(6) 2023 his inr at the hospital was 5.4 while it was 3.4 on his meter prior to going to the hospital.The daughter did not know whether this was within 4 hours.Although the results may be discrepant, the daughter did state that when the patient was found to be confused, he was taking too much warfarin.This may have contributed to his higher inr at the hospital.This is substantiated, as his inr continued to rise at the hospital requiring the patient to receive vitamin k the next day.Furthermore, this possible discrepancy did not significantly impact the patient¿s clinical course as the patient was actually supratherapeutic which would not place him at increased risk of an ischemic/embolic stroke.The coaguchek xs meter serial number was (b)(6).The meter and test strips were requested for investigation.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.".

Manufacturer Narrative

Section b7 was updated.The meter and test strips were provided for investigation where they were tested using retention controls.Section d9 was updated.Testing results (qc range = 2.5 ¿ 3.5 inr): qc 1: 3.0 inr qc 2: 3.0 inr qc 3: 3.0 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 investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 17888925
• MDR Text Key: 325135453
• Report Number: 1823260-2023-03220
• 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: K062925
• 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: 10/27/2023

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: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 65031521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/27/2023
• 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: WARFARIN
• Patient Sex: Male