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

Catalog Number 04625374160

Device Problems Device Difficult to Setup or Prepare (1487); Non Reproducible Results (4029)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

The reporter initially called due to an error 5.Product labeling states "error 5: blood application error applying blood to the test strip.Solution: power the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger." on a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.Section e3 - occupation: patient/consumer.

Event Description

We received an allegation of a questionable inr result for one patient tested with the coaguchekxs meter with serial number (b)(6) compared to another coaguchek meter with an unknown serial number.The reporter initially called due to an error 5.During the call, she mentioned that she found a discrepancy when she compared the meter results to the result from her doctor's meter.The result from the reporter¿s meter at 11:36 am was 2.1 inr.The result from the reporter¿s meter at 11:38 am was 1.7 inr.The result from the doctor¿s meter at 2-2:30 pm was 2.4 inr.The patient's therapeutic range is 2.0 to 3.0 inr.The interval of testing is weekly.

• 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: 17711572
• MDR Text Key: 322972162
• Report Number: 1823260-2023-02925
• 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
• Report Date: 09/08/2023

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: 04/30/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 65779321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/08/2023
• 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: AZELASTINE; BUSPIRONE; CLONAZEPAM; DEPLINE; FLECAINIDE; FLUTICASONE; FUROSEMIDE; LEVOTHYROXINE; MAGNESIUM; METOPROLOL; MULTIVITAMIN; OMEPRAZOLE; POTASSIUM CHLORIDE; PROBIOTIC; VILAZODONE; VITAMIN D; WARFARIN
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 191 KG