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

Catalog Number 04625374160

Device Problem Low Test Results (2458)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

The coauchek xs meter serial number was (b)(6).The meter and test 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.

Event Description

We received an allegation of a low inr result for 1 patient tested with coaguchek xs meter that may have contributed to the patient requiring treatment with vitamin k for high inr and a nosebleed.On 10-oct-2023 the patient allegedly woke up with a nosebleed that he was unable to stop on his own.At 9:00 a.M.The patient reportedly had a meter result of 2.6 inr at home.His wife reportedly drove him to the emergency room and the patient's laboratory result was reported to be over 7.0 inr.The time difference between the testing measurements was reported to be about an hour.The patient was allegedly treated with an intravenous vitamin k.The nosebleed was reportedly treated with a rhino rocket that the patient had to keep in for 3 days.It was reported that the physician stated that the source of the bleeding was weakened veins.The patient's therapeutic range was 2.0-3.0 inr.The patient's interval of testing was once per week.

Manufacturer Narrative

The type of investigation code was updated.No product is expected to be returned.There was no data or information provided to reasonably suggest the device malfunctioned or would point to a cause for the discrepancy in the results.The investigation did not identify a product problem.

• 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: 18161993
• MDR Text Key: 328424985
• Report Number: 1823260-2023-03651
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 68883822
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/21/2023
• 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: AMLODIPINE; CALCITRIOL; IRON SUPPLEMENT; LASIX; LOSARTAN; METOPROLOL; OTC CETIRIZINE; OTC MULTI-VITAMIN - LONG TERM USE; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male