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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

The coaguchek xs meter's serial number is (b)(6).The doctor's meter serial number was not provided, and the meter type is unknown.The initial reporter stated the doctor's meter looked exactly like the patient's coaguchek xs meter.The product was 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.

Event Description

There was an allegation of questionable results from a patient's coaguchek xs meter compared to the doctor's meter.The result on the coaguchek xs meter was 1.9 inr.The result on the doctor's meter was 2.4 inr.The date of the event is unknown.The results were received within a few hours of each other.The patient's therapeutic range is 2.0-2.5 inr.

Manufacturer Narrative

The returned meter was tested with retention strips and with retention roche qc level 1 and level 2 controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.3 inr.Level 2 testing results (qc range = 2.4 - 3.6 inr): qc 2: 2.9 inr.The obtained results were in the allowed range.No error messages occurred during the investigation.The customer's alleged result of 2.1 inr on (b)(6) 2023 was not observed in the meter's patient result memory.Instead, a result of 2.1 inr was observed on (b)(6) 2023.The customer's alleged result of 2.1 inr on (b)(6) 2023 was not observed in the meter's patient result memory.Instead, a result of 2.5 inr was observed on (b)(6) 2023.The customer's alleged result of 2.0 inr in (b)(6) 2023 was not observed in the meter's patient result memory.A review of the meter's patient result memory observed that the most recent occurrence of the alleged result of 1.9 inr was on (b)(6) 2023.The investigation did not identify a product problem.The cause of the event 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18328159
• MDR Text Key: 330576279
• Report Number: 1823260-2023-04006
• 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,Followup
• Report Date: 12/22/2023

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/22/2023
• 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: ATORVASTATIN.; CALCIUM.; CARVEDILOL.; FEUROSIMIDE.; JARDIANCE.; POTASSIUM.; PREDNISONE.; STATIN.; TRULICITY.; VITAMIN B12.; VITAMIN D.; WARFARIN.; ZYRTEC.
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 62 KG