MalfunctionMRZ
ADAPTER ACC-1003911D NGP
Received Mar 15, 2022 · Event occurred Dec 1, 2021
Report 2032227-2022-139577 · MDR key 13772456
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Medtronic MinimedModel number
ACC-1003911DCatalog number
ACC-1003911D
Product problems
- Computer Software Problem
- Computer Software Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT SOFTWARE ERROR OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.