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	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's softclix device and lancets have been requested for investigation.Medwatch field initial reporter occupation: occupation - the occupation is patient/consumer.
Event or Problem Description
It was alleged that there was an issue with a coaguchek softclix lancing device.The customer advised that the device pokes too deep or it does not poke deep enough.The cap of the device also falls off and has been falling off for a while.The lancet does not retract when it pokes too deep.The customer stated the softclix device was set to "5.5".The lancet was seated properly in the device when not retracted.The lancet did not protrude past the end of the cap of the device.
Additional Manufacturer Narrative
The lancing device was returned for investigation.The customer's allegation could not be reproduced.The device was in functional condition.The lancing device was tested with some test lancets (lot u21a8) 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.In addition, the cap had a snug fit on the lancing device and did not come off easily.The lancing device was disassembled for investigation and no abnormalities could be observed which could verify the customer allegation.The customer's lancets were not returned for investigation.A review on complaint data was performed with specific focus on the alleged failure "lancet not retracted" and the reported lot number (bbf003).No increased cumulation of the alleged failure was identified for the affected production interval.
Additional Manufacturer Narrative
Medwatch field d4 has 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: 16241676
• Report Number: 1823260-2023-00226
• Device Sequence Number: 6606079
• 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,Followup
• Report Date (Section B): 04/21/2023

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: BBE003
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 04/20/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/06/2023; 04/21/2023
• 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