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	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of an issue with a coaguchek xs softclix lancet device.The customer alleged the lancet was protruding from the end cap of the device.The correct lancets were being used.The lancet was properly seated in the carrier.The customer stated the middle part of the device is loose and it won't stay up against the plunger at the end of the device.The customer is unable to prime or fire the device.No accidental stick occurred.
Additional Manufacturer Narrative
The lancet device was requested for investigation.Section e3: occupation is patient/consumer.Section h4: the year is the only known part of manufacture date.We have defaulted to the first of the year.
Additional Manufacturer Narrative
The lancet device was received for investigation.The customer's allegation was not reproduced during the investigation.The lancet device was tested with test lancets at 11 different depth settings.For each attempt, the lancet needle produced a puncture hole, retracted, and ejected correctly.The lancet device was primed and released with no issues.The lancet device was disassembled for further investigation.No abnormalities were observed that would explain the customer's allegation.Complaints regarding this allegation and the specific lot number involved were reviewed and showed no increase for the affected production interval.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• 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 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16835206
• Report Number: 1823260-2023-01432
• Device Sequence Number: 7536871
• 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): 05/18/2023

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: BBG110
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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: Male