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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCU-CHEK® TENDERLINK; COMFORT SHORT 80/13
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ACCU-CHEK® TENDERLINK; COMFORT SHORT 80/13 Back to Search Results
Lot Number 5058501
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
Unomedical reference number (b)(4) event occurred in the (b)(6).The patient reported that tubing was disconnected from the head set.No further information available.
 
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Brand Name
ACCU-CHEK® TENDERLINK
Common Device Name
COMFORT SHORT 80/13
MDR Report Key8300455
Report Number8021545-2019-00104
Device Sequence Number10801820
Product Code FPA
UDI-Device Identifier05705244008830
UDI-Public05705244008830
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 Date01/31/2019
Device Lot Number5058501
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/16/2017
Initial Report FDA Received Date02/03/2019
Patient Sequence Number1
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