FIRST SIGNAL TM. FHC-102H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for FIRST SIGNAL TM. FHC-102H manufactured by Spd Swiss Precision Diagnostics, Gmbh.

Event Text Entries

[112727321] Hcg pregnancy test otc, first signal manufactured by spd. I took this pregnancy test after missing my period for 11 days. I had 3 positive pregnancy test, when i went to my gynecologist, gynecologist said i was not pregnant. This hcg pregnancy test from first signal gave 3 false positive, making this test very inaccurate. The box claim over 99% accurate and obviously this is not only misleading but inappropriate that a product in the market causes false positives. Hcg pregnancy test first signal: lot number: hcg7120011, exp 11/30/2019.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078133
• MDR Report Key: 7645719
• Date Received: 2018-06-27
• Date of Report: 2018-06-26
• Date of Event: 2018-05-13
• Date Added to Maude: 2018-06-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FIRST SIGNAL TM.
• Generic Name: KIT, TEST PREGNANCY, HCG
• Product Code: LCX
• Date Received: 2018-06-27
• Catalog Number: FHC-102H
• Lot Number: HCG7120011
• Device Expiration Date: 2019-11-30
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPD SWISS PRECISION DIAGNOSTICS, GMBH

Device Sequence Number: 2

• Brand Name: FIRST SIGNAL TM.
• Generic Name: KIT, TEST PREGNANCY, HCG
• Product Code: LCX
• Date Received: 2018-06-27
• Catalog Number: FHC-102H
• Lot Number: HCG7120011
• Device Expiration Date: 2019-11-30
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SPD SWISS PRECISION DIAGNOSTICS, GMBH

Device Sequence Number: 3

• Brand Name: FIRST SIGNAL TM.
• Generic Name: KIT, TEST PREGNANCY, HCG
• Product Code: LCX
• Date Received: 2018-06-27
• Catalog Number: FHC-102H
• Lot Number: HCG7120011
• Device Expiration Date: 2019-11-30
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SPD SWISS PRECISION DIAGNOSTICS, GMBH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-06-27