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 Problems Balance Problems (4401); Hemorrhagic Stroke (4417); Ischemia Stroke (4418)

Event Date 07/04/2022

Event Type  Injury  

Event Description

The initial reporter contacted technical support for assistance with error 3 from the coaguchek xs meter serial number (b)(4) and mentioned the patient had been hospitalized for a brain bleed.On (b)(6) 2022, the result reported to be from the meter was 2.9 inr.No dosage changes were made.On (b)(6) 2022, the result reported to be from the meter was 2.8 inr.No dosage changes were made.The reporter explained that for results that were 3.1 inr or above, she would have been told to withhold the patient's warfarin dose for 1 or 2 days and then return to his normal dose.On (b)(6) 2022 around 4:30 am, the patient allegedly woke up to go to the bathroom and his left leg, arm, and hand were asleep but it was believed this was due to having slept on them wrong.The patient allegedly was able to get dressed, walk down the stairs, and do the work without issue.When returning home, the patient allegedly slightly stumbled when walking up the three steps to the house, but allegedly did not think this was unusual.At lunchtime, the patient allegedly had trouble eating, so his wife took him to the er.A ct, mri, and inr testing were allegedly performed.Allegedly, a small brain bleed was found in the back lower left of his brain.The reporter could not recall the actual location in the brain.The result reported to be from the hospital laboratory using an unknown reagent was 4.3 inr.The patient did not test with the meter on this date.Allegedly, the patient's doctor stated that the patient's blood was too thin and took the patient off all warfarin.Allegedly between (b)(6) 2022 and the morning of (b)(6) 2022, the patient had a stroke on the opposite side of his brain.The patient was allegedly placed on a ventilator for 7 days.The patient's doctor allegedly stated that he believed the patient's blood got too thick and that is the risk when trying to manage a bleed.The patient was reportedly started on baby aspirin.The patient was reported to be in the hospital from (b)(6) 2022 and then was in rehab from (b)(6) 2022.Allegedly, the patient had trouble with his eye and his left side after the stroke but reportedly has made a nearly full recovery.The patient has reportedly been recovering at home and is doing well.The patient allegedly still walks with a walker most of the time for stability.The patient's therapeutic range is 2.0-2.5 inr.The testing frequency was reported to be monthly and had recently switched to every two weeks, but according to the reporter, they allegedly forgot a lot.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The cause of error 3 was determined to be that the date of the meter was set to a future date of 2023.The date on the meter was corrected which resolved the issue.Per product labeling for error 3: the test strip has expired.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.The meter was requested for return.The strips are no longer available to be returned.No product has 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 was patient/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: 15411432
• MDR Text Key: 299788132
• Report Number: 1823260-2022-02821
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• 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: "OTHER VARIED VITAMINS".; METOPROLOL.; NIFEDIPINE.; PRESERVISION.; SAW PALMETTO.; SPIRONOLACTONE.; VITAMIN B.; WARFARIN.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 91 KG