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

Catalog Number 04625374160

Device Problems Off-Label Use (1494); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The coaguchek xs meter's serial number was (b)(6).The 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.The patient was advised about the below limitations with reference to the package insert and he was also advised to contact his doctor.Product labeling states: "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician." product labeling states: "hematocrit ranges between 25-55 % do not significantly affect results." since the acceptable range for coaguchek system is 25-55% and the patient's hct is currently 55.7% and has been as high as 70%, then this would put both results out of range.The patient pricked the same finger for the other measurement.For a second measurement a new puncture of a different finger is mandatory.Product labeling states: "if you need to redo a test, use a new lancet, a new test strip, and a different finger.".

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs meter.On (b)(6) 2023 the patient had the following meter results: initial result: 1.6 inr at 9:37 a.M.1st repeat result: 1.7 inr at 9:39 a.M.(tested using the same finger) 2nd repeat result: 2.1 inr at 9:39 a.M.(tested using the new finger).The patient's therapeutic range was 2.0-3.0 inr and the interval of testing is every 2 weeks.

Manufacturer Narrative

The patient did not return the meter for investigation.As no product was returned, a specific root cause 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17319791
• MDR Text Key: 319117396
• Report Number: 1823260-2023-02247
• 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,Followup
• Report Date: 08/24/2023

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: 636658921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/24/2023
• 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: ALLOPURINOL.; ASPIRIN.; BUMEX.; CYCLOBENZAPRINE.; DULOXETINE.; EPLERENONE.; FASENRA.; GABAPENTIN.; HYDROCODONE.; ISOSORBIDE.; JARDIANCE.; LISINOPRIL.; MAGNESIUM.; METOLAZONE.; METOPROLOL.; MIDODRINE.; MIRTAZAPINE.; PANTOPRAZOLE.; POTASSIUM.; ROSUVASTATIN.; VITAMIN D3.; WARFARIN.; XANAX.
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 100 KG