MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK SOFTCLIX; BLOOD LANCET

Catalog Number	07313462001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer the device was requested for investigation.
Event or Problem Description
There was an allegation of an issue with a coaguchek softclix lancet device.The patient alleged the lancet was sticking out of the end cap of the device.The patient stated the lancet was "in the device all the way." when the cap was placed on the device, the lancet stuck out of the end cap.The patient accidentally stuck their finger with the lancet; the patient was not harmed due to the accidental stick.
Additional Manufacturer Narrative
The softclix lancing device was returned for investigation.The reported failure on protruding lancets could not be confirmed during investigation.The lancing device was tested with some test lancets at 11 different pricking depth settings, for each attempt needle was correctly retracted, rejected and produced a puncture hole.The failure could not be confirmed during investigation.No malfunction or defect was observed during testing.Medwatch fields d4, d9 and h3 have been updated.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ASKU; asku; na; asku
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16113398
• Report Number: 1823260-2023-00075
• Device Sequence Number: 5655068
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 03/27/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 07313462001
• Device Lot Number: BBA020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/27/2023
• 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
• Patient Sex: Female