MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK SOFTCLIX; LANCET DEVICE

Model Number	ACCU-CHEK SOFTCLIX
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of an issue with an accu-chek softclix lancet device.The reporter initially called for assistance in testing.As the reporter was attempting to puncture the finger with the accu-chek softclix device, the reporter noticed that the lancet was exposed and protruding from the end of the cap.The reporter stated that the lancet and cap were properly seated in the device.
Additional Manufacturer Narrative
The lancet device was requested for investigation.Occupation is patient/consumer.The year is the only known part of the manufacture date.We have defaulted it to the first of the year.
Additional Manufacturer Narrative
The lancet device was returned for investigation.The reported failure on protruding lancets could not be confirmed during investigation.The lancing device was in a functional condition.The lancing device was tested with some test lancets 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 d9 and h3 have been updated.

• Brand Name: ACCU-CHEK SOFTCLIX
• Common Device Name: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; pfriemd 92536 ; GM 92536
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16280072
• Report Number: 1823260-2023-00293
• Device Sequence Number: 12505769
• Product Code: FMK
• UDI-Device Identifier: 00365702400108
• UDI-Public: 00365702400108
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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 Model Number: ACCU-CHEK SOFTCLIX
• Device Catalogue Number: 05509661001
• Device Lot Number: WIM059
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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