AMNISURE ROM TEST
Received Feb 19, 2020 · Event occurred Nov 29, 2019
Report 1122376-2020-00002 · MDR key 9730230
Device
Generic name
Amnisure Rom Test
Manufacturer
Qiagen Sciences, LlcModel number
FMRT-1Catalog number
FMRT-1-25-US
Lot number
56307021
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) 2019 CUSTOMER REPORTED UNEXPECTED NEGATIVE AMNISURE RESULTS FOR 3 PATIENTS WITH NO ADVERSE OUTCOMES. ADDITIONAL INFORMATION AND RETURN PRODUCT WAS REQUESTED FROM CUSTOMER. FOLLOW UP INFORMATION WAS RECEIVED 1/28/2020. THE MALFUNCTION WAS NOT CONFIRMED ON RETURNED MATERIAL, HOWEVER WAS OBSERVED IN RETAINED PRODUCT TESTING AT A RATE WITHIN THE LABELED PERFORMANCE CHARACTERISTICS OF THE PRODUCT. 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, GROSSLY RUPTURED, FERNING AND POOLING POSITIVE, AND AMNISURE NEGATIVE. PATIENT ADMITTED AND SUCCESSFULLY DELIVERED.