MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SC LANCING DEVICE KIT

Catalog Number	08120242001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a retraction issue with the coaguchek xs softclix device.The reporter wanted to confirm if the lancet was seated correctly each of the three times it poked out of the end of the cap when priming.The reporter stated that the needle "poked out" of the cap when they were priming the device which occurred three times.On troubleshooting, the reporter stated that the needle was not showing when the cap was put on and the needle came out when the device was primed.The reporter stated that they had to reprime the device a few times before the needle retracted and was ready for use.The reporter also mentioned that recently, the lancet had not been lancing the finger as well.The reporter stated there were no accidental finger sticks and that they were able to get the device to work correctly afterward to complete the test.
Additional Manufacturer Narrative
The user's device was requested for investigation and a replacement product was sent to the user.The investigation is ongoing.Medwatch field e3.Occupation - the occupation is patient/consumer.Due to a lack of information from the complainant, we were unable to determine the actual manufacturer of the product, and g1 manufacturing site information reflects the same information as the g1 contact office.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, lot no, device available for evaluation, and h3 device evaluated by mfg were updated.The lancing device was received for investigation and was tested with test lancets at 11 different pricking depth settings on a rubber mat.For each attempt, the needle was correctly retracted, ejected, and produced a puncture hole.The lancing device could be primed and released.The lancing device was disassembled for investigation and no abnormalities were noted.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK XS SC LANCING DEVICE KIT
• Common Device Name: LANCING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; bad oeynhausen IN 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18928607
• Report Number: 1823260-2024-00800
• Device Sequence Number: 11907257
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 08120242001
• Device Lot Number: BBA145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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