AMNISURE ROM TEST
Received Feb 24, 2020 · Event occurred Jan 21, 2020
Report 1122376-2020-00004 · MDR key 9747868
Device
Generic name
Amnisure Rom Test
Manufacturer
Qiagen Sciences, LlcModel number
FMRT-1Catalog number
FMRT-1-25-US
Lot number
56309689
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2020 CUSTOMER REPORTED UNEXPECTED NEGATIVE AMNISURE RESULTS WITH NO ADVERSE OUTCOMES. CUSTOMER INDICATED THAT THE TEST WAS PERFORMED CORRECTLY. TIME BETWEEN ONSET OF ROM SYMPTOMS AND THE AMNISURE TEST IS NOT KNOWN. THE LOT IS PERFORMING WITHIN SPECIFICATIONS. NO OTHER CUSTOMERS HAVE REPORTED ISSUES WITH THIS LOT. QIAGEN'S OVERALL EVALUATION DOES NOT INDICATE A SYSTEMIC PROBLEM WITH THIS LOT.
Description of Event or Problem
A CUSTOMER REPORTED PATIENT IN LABOR AND GROSSLY RUPTURED AND AMNISURE NEGATIVE. PATIENT ADMITTED AND SUCCESSFULLY DELIVERED.