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

Catalog Number	04625315160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable inr results for (1) patient with coaguchek xs meter cpl.Customer's therapeutic range is 2.5-3.5 inr.This report is related to mfg report no 1823260-2024-02448 (reported on coaguchek vantus).This medwatch is reporting on the coaguchek xs meter cpl used at doctor's office.Patient reported the following: on (b)(6) 2024 at 8:35 am the patient received a result of 4.8 inr on the vantus meter.On (b)(6) 2024 at 10:42 am the patient received a result of 3.5 inr on the vantus meter.1-2 hours later, the patient had a test conducted at the doctor's office using a coaguxs meter and received a result of 3.6 inr.Healthcare provider at doctor's office reported: patient was tested on the office meter on (b)(6) 2024 at 2:11 pm receiving a result of 3.9 inr.Patient tested using home meter and received a result of 4.3 inr.Meter to lab comparison was greater then 4 hours.
Additional Manufacturer Narrative
Coaguchek vantus serial number is (b)(6).Coaguxs meter serial number is (b)(6).The device was not returned for investigation.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.Section e3: occupation is patient/consumer.
Additional Manufacturer Narrative
The type of investigation code was updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: 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: 20047339
• Report Number: 1823260-2024-02454
• Device Sequence Number: 20822175
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 04625315160
• Device Lot Number: 74976511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ALBUTEROL; AMIODARONE; ASCORBIC ACID; BUSPIRONE HCL; CARVEDILOL; DOXYCYCLINE HYCLATE; ENTRESTO; FERROUS SULFATE; FISH OIL OMEGA; FUROSEMIDE; JARDIANCE; LOPERAMIDE; LUTEIN; MAG-OX; MOMETASONE; MULTIVITAMIN; PROBIOTIC; ROSUVASTATIN; SPIRONOLACTONE; TAMSULOSIN; TAMSULOSIN; VITAMIN C; VITAMIN D3; VITAPRO; WARFARIN; ZOLOFT; ZYRTEC
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 96 KG