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

Catalog Number	07797826160
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of error messages, an incorrect date, and low results from coaguchek xs meter serial number (b)(4).The customer could not remember specific date of the event other than "it was a long time ago".The customer could not remember specific results.He alleged the result from the meter was low (below 2.0 inr) and a repeat test was inside his therapeutic range of 2.5-3.5 inr.The customer tests once a month.
Additional Manufacturer Narrative
The customer purchased the meter and strips from amazon.Products should only be purchased from approved distributors.The customer was assisted with setting up the meter and setting the date/time.The customer had received an error 4.Per product labeling: the test strip is unusable.Turn the meter off, remove the test strip, and then re-insert it.If the error message reappears, discard the unusable test strip and use a new one.The customer noticed the cover was not on the vial.Therefore, the strips had been exposed to air.Per product labeling for the test strips: the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician.The products have been requested for return.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.Occupation was patient/consumer.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15496536
• Report Number: 1823260-2022-02958
• Device Sequence Number: 12029470
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: 09/30/2022
• Device Catalogue Number: 07797826160
• Device Lot Number: 53224012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: "OVER THE COUNTER VITAMINS"; FISH OIL; HYDROXYCHLOROQUINE; PREDNISONE; TUMERIC; WARFARIN
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 74 KG