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 Problem Thromboembolism (2654)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

The reporter's meter and test strips were requested for investigation.The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.(b)(6).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 allegedly received an "error 3".On the call, it was determined that the customer was using the code chip from a previous lot the customer was using.Once the correct code chip was inserted for the lot in use, error 3 was resolved.The strip product labeling states: "error 3: test strip expired - the test strip has expired.Solution: check the meter¿s date setting.If it is not correct, set the correct date.For more information, see the meter setup section of this manual.If the date is correct, turn the meter off and remove the code chip and the test strip.Then use the code chip and a test strip from a new box of test strips." product labeling states: "before each test, make sure the correct code chip is in the meter.Each time you open a new box of test strips, replace the old code chip with the new one." the customer stated they were taking antibiotics.Product labeling states: "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter called alleging receiving an "error 3" from the coaguchek xs meter with serial number (b)(4).On the call, the reporter also mentioned that the patient is in the hospital due to an alleged blood clot in his titanium heart valve.On (b)(6) 2022 at 4:49 pm the meter result was 2.1 inr.On (b)(6) 2022 at 6:48 pm the meter result was 2.8 inr on an unspecified date, prior to (b)(6) 2022, the patient reportedly had a heart catheter procedure at his local veteran's affairs (va) hospital.On (b)(6) 2022, the patient was allegedly brought to the emergency room (er) as he was reportedly having trouble breathing.At the er, they reportedly found a blood clot in the titanium aortic heart valve.They reportedly thought that the patient had a blood clot due to a low inr.He reportedly had to take augmentin for 21 days.During the hospital stay, the patient was also allegedly treated with a heparin drip and lovenox injections.He reportedly had a procedure to break up the blood clot.The patient was reportedly in the hospital until (b)(6) 2022.The patient has reportedly been adjusting his warfarin dose according to the meter reading.The therapeutic range was reported to be 2.0 to 3.0 inr.The interval of testing was reported to be once a week.

• 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: 14548815
• MDR Text Key: 292988396
• Report Number: 1823260-2022-01561
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54145321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Date Manufacturer Received: 05/02/2022
• 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: ASMANEX; LEVOTHYROXINE; PANTOPRAZOLE; QVAR; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG