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	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's softclix device was requested for investigation.Medwatch field initial reporter.Occupation - the occupation is patient/consumer.
Event or Problem Description
It was reported that there was an issue with a coaguchek xs softclix lancing device.The user was able to eject a lancet used for a previous test.When the user put in a new lancet, the exposed needle was sticking out of the end cap of the device.The user confirmed the needle was properly seated in the lancing device and the end cap was properly seated in place.
Additional Manufacturer Narrative
The lancet device was returned for investigation.The reported failure of protruding lancets could not be confirmed during investigation.The returned device was tested at 11 different pricking depth settings, for each attempt needle was correctly retracted, ejected and produced a puncture hole.The lancing device could be primed and released without any problems and works in accordance with specifications.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 Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16036840
• Report Number: 1823260-2022-04166
• Device Sequence Number: 5463238
• 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: BBI052
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 12/22/2022
• 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: Unknown