PILOT COVID-19 AT-HOME TEST
Received May 16, 2023 · Event occurred Mar 29, 2023
Report MW5117584 · MDR key 16946779
Device
Generic name
Coronavirus Antigen Detection Test System
Manufacturer
Sd Biosensor, Inc.Catalog number
99COV200L-EN02
Lot number
53K38P2T1
Product problems
- Contamination
- False Negative Result
- Nonstandard Device
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON FOUR CONSECUTIVE DAYS I USED SD BIOSENSOR PILOT COVID-19 AT-HOME TESTS WITH LOT #53K38P2T1 THAT WERE LATER RECALLED BY THE FDA DUE TO BACTERIAL CONTAMINATION. I DID NOT HAVE ANY SIGNS OF BACTERIAL INFECTION, BUT I SUSPECT FALSE NEGATIVE RESULTS, WHICH IS LISTED AS A CONCERN IN THE RECALL INFORMATION. I USED THE TESTS BECAUSE I HAD COVID SYMPTOMS STARTING 3 TO 4 DAYS AFTER A CONFIRMED EXPOSURE. I CONTINUED TO HAVE SYMPTOMS FOR 3 TO 4 WEEKS. AFTER A WEEK OF ILLNESS I CALLED MY HEALTH CARE PROVIDER (B)(6), AND A NURSE THERE ADVISED THAT I DID NOT NEED TO COME IN FOR A PCR TEST, PARTLY BECAUSE OF THE NEGATIVE HOME TEST RESULTS WHICH ARE NOW IN QUESTION. REFERENCE REPORTS MW5117581, MW5117582, MW5117583.