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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay for detection of amniotic fluid protein(s).
Definition The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Product CodeNQM
Regulation Number 862.1550
Device Class 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 5 5
2020 5 5
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Difficult to Remove 2 2
Adverse Event Without Identified Device or Use Problem 2 2
False Positive Result 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9 9
Death, Intrauterine Fetal 3 3
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Abscess 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Dec-07-2020
2 Qiagen Sciences LLC II Apr-01-2020
3 Qiagen Sciences, Inc. I Jul-13-2018
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