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

Catalog Number 04625315160

Device Problem Non Reproducible Results (4029)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable results from a coaguchek pro meter.At 6:51 am, the initial result from the patient meter (serial number (b)(6) was 1.3 inr.At 9:07 am, the patient went to the doctor's office and the result from the professional meter was 3.3 inr.The retest result using the patient's meter and the test strips from the doctor's office was 3.1 inr.The therapeutic range was 2.5-3.5 inr and the patient tests weekly.The patient had a dietary change of eating oranges.

Manufacturer Narrative

The coaguchek professional meter serial number was (b)(6).Quality controls were tested on the pro meter and passed.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.

• 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: 19011061
• MDR Text Key: 339011393
• Report Number: 1823260-2024-00968
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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: Health Professional
• Device Catalogue Number: 04625315160
• Device Lot Number: 73389513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLARITIN; CRESTOR; FLOMAX; GLIPIZIDE; JANTOVEN; JANUVIA; JARDIANCE; LASIX; MECLIZINE; METFORMIN; METOPROLOL; MULTAQ; NORCO; TOTAL BEETS; TRICOR
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG