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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SC LANCING DEVICE KIT
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ROCHE DIAGNOSTICS COAGUCHEK XS SC LANCING DEVICE KIT Back to Search Results
Catalog Number 08120242001
Medical Device Problem Code Retraction Problem (1536)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/31/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Occupation ni equals lay user/patient.
 
Event or Problem Description
The patient stated that a lancet was protruding from the end cap of his coaguchek xs sc lancing device.The lancet was properly seated within the device.There was no allegation of an adverse event.There were no injuries related to the protruding lancet.The patient's product was requested for investigation and a replacement product was sent to the patient.
 
Additional Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.
 
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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
MDR Report Key8075078
Report Number1823260-2018-04337
Device Sequence Number2325402
Product Code FMK
UDI-Device Identifier00365702702165
UDI-Public00365702702165
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/07/2019
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 Number08120242001
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Initial Date Received by Manufacturer 10/31/2018
Supplement Date Received by Manufacturer10/31/2018
Initial Report FDA Received Date11/15/2018
Supplement Report FDA Received Date01/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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