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

Catalog Number 07313462001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of a coaguchek xs softclix lancet that was not working properly.The customer stated that the lancet was barely able to puncture their finger and that the lancet needle is extending past the cap.The customer stated that they were able to seat the lancet in place and set the depth setting.

Manufacturer Narrative

The lancet device was not received for investigation.Complaints regarding this allegation and the specific lot number involved were reviewed and showed no increase for the affected production interval.No product problem was identified.The root cause of the event could not be determined.

• Brand Name: COAGUCHEK SOFTCLIX
• Type of Device: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH AND CO. KG; bergkichener str. 228; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17484141
• MDR Text Key: 320633546
• Report Number: 1823260-2023-02561
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07313462001
• Device Lot Number: BBA145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1