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	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for investigation.The serial number of the coaguchek xs plus meter is (b)(6).The serial number for the patient's coaguchek-xs meter is (b)(6).All test strip retention samples passed the internal inspection and are inconspicuous.On a regular basis, coaguchek strips of all lots currently valid in the market are tested in comparison to the current master lot at roche mannheim.For this purpose, the strips are measured with two human blood samples from marcumar donors and one high level control sample on internal reference meters.Section e3: occupation is patient/consumer.
Event or Problem Description
We received an allegation of questionable results on a coaguchek xs plus when compared to the patient's coaguchek xs meter.On (b)(6) 2024 at 1:22pm, the patient received the following inr results: patient's coaguchek xs meter result 1.2 on (b)(6) 2024 at 1:30pm, the patient received the following inr results: clinic's coaguchek xs meter result 6.6 the patient¿s therapeutic range was provided 2.5 - 3.0 inr.Interval of testing is 1 x week.

• 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: 19938204
• Report Number: 1823260-2024-02302
• Device Sequence Number: 7319719
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 04625315160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/08/2024
• 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
• Patient Sex: Unknown