MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 3RD GENERATION PSA

Model Number IMMULITE/IMMULITE 1000 3RD GENERATION PSA

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed negative bias with immulite® /immulite® 1000 third generation psa (prostate-specific antigen) kit lots 336, 337, d0119 and d0120 only.The investigation by siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/ml.The quality controls show a similar negative bias as seen with patient results.Depending on the quality control ranges used by the laboratory, this issue may not be identified by quality control material.The issue only impacts the immulite/immulite 1000 third generation psa.An urgent field safety notice (ufsn) imc 17-05.A.Ous was sent to ous customers and an urgent medical device recall (umdr) imc17-05.A.Us was sent to us customers in december 2016.The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lot.

Event Description

The customer reported low recovery with quality controls (qc) when using immulite third generation prostate specific antigen (3rd generation psa) kit lot 0337.The customer did not run any patient samples while quality control was out of range.There was no impact on patient testing or delay in reporting of results.There are no known reports of patient intervention or adverse health consequence due to the low recovery of 3rd generation psa on qc.

• Brand Name: IMMULITE/IMMULITE 1000 3RD GENERATION PSA
• Type of Device: IMMULITE/IMMULITE 1000 3RD GENERATION PSA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 6222718
• MDR Text Key: 63869959
• Report Number: 2432235-2017-00009
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE/IMMULITE 1000 3RD GENERATION PSA
• Device Catalogue Number: LKUP
• Device Lot Number: 0337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-12/22/2016-003R
• Patient Sequence Number: 1