IMMULITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-11 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[83749210] The operator of the immulite instrument called the siemens customer care center (ccc) to report a thyroid stimulating hormone (rapid tsh) discordant low patient result. The ccc specialist inquired about the instrument performance and was informed that all maintenance was up to date. The operator confirmed all reagents were handled in accordance with package insert directions, all quality controls (qc) are resulting in range, and there were no errors posted at the time of testing. Since the operator could not perform any additional troubleshooting, the operator called back and informed the ccc that repeat testing was performed to confirm the correct patient result. In addition, the operator also clarified that the affected sample was frozen and thawed between each repeat testing. The ccc then provided instructions to run several diagnostics tests to ensure no mechanical or fluidic issues. After the all instructions were performed, the operator confirmed no air or leaks in fluidics, syringes operate as normal, pipettor level sensing is operational, and no issues with the substrate dispense or wash spinner speed. The cause of the discordant, falsely low rapid tsh result on one patient sample is unknown. The instrument is performing according to the specifications and no further evaluation of this device is required. The instrument was manufactured before september 2016, and udi number is not available.
Patient Sequence No: 1, Text Type: N, H10

[83749231] A single thyroid stimulating hormone (rapid tsh) discordant low patient result was obtained on an immulite instrument. The discordant result was reported to the healthcare practitioner who questioned the result. The operator repeated testing twice and the patient sample resulted high. The 1st repeat result was reported to the healthcare practitioner and in line with the expected clinical profile. There were no reports of medical treatment or intervention administered or withheld because of the discordant patient result.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2247117-2017-00086
• MDR Report Key: 6788331
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2017-08-11
• Date of Report: 2017-08-11
• Date of Event: 2017-07-12
• Date Mfgr Received: 2017-07-19
• Date Added to Maude: 2017-08-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ROLANDO HUALPA
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN NY 10951
• Manufacturer Country: US
• Manufacturer Postal: 10951
• Manufacturer Phone: 9145242963
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Street: 62 FLANDERS BARTLEY RD REGISTRATION #: 2247117
• Manufacturer City: FLANDERS NJ 07836
• Manufacturer Country: US
• Manufacturer Postal Code: 07836
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: IMMULITE
• Generic Name: IMMULITE
• Product Code: JLW
• Date Received: 2017-08-11
• Model Number: IMMULITE
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Address: 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836

Device Sequence Number: 1

• Brand Name: IMMULITE
• Generic Name: IMMULITE
• Product Code: JJQ
• Date Received: 2017-08-11
• Model Number: IMMULITE
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Address: 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-11