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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCU-CHEK® TENDERLINK; COMFORT SHORT 60/13
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ACCU-CHEK® TENDERLINK; COMFORT SHORT 60/13 Back to Search Results
Lot Number 5204198
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
(b)(4).Event occurred in (b)(6).It was reported that the tube at the level of connection part with needle got loose.No further information available.
 
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Brand Name
ACCU-CHEK® TENDERLINK
Common Device Name
COMFORT SHORT 60/13
MDR Report Key8342369
Report Number8021545-2019-00112
Device Sequence Number1959135
Product Code FPA
UDI-Device Identifier05705244008502
UDI-Public05705244008502
Combination Product (Y/N)N
PMA/510(K) Number
K162812
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
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 No Information
Device Expiration Date10/01/2022
Device Lot Number5204198
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2018
Initial Report FDA Received Date02/15/2019
Patient Sequence Number1
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