MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE / IMMULITE 1000 AFP

Model Number IMMULITE / IMMULITE 1000 AFP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that they checked their quality controls and adjustments, which were acceptable.A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer and stated that as per immulite 1000 afp instructions for use, "values obtained with different afp assays cannot be used interchangeably.Before changing assays, the laboratory must confirm baseline values for patients being serially monitored".The hsc specialist stated that if the patient is baselined on one platform, they need to stay on that platform.Since this was the first time this patient was run on the immulite 1000 instrument, the patient would need to be baselined.The hsc specialist reviewed quality controls for all assays and other patient samples evaluated for afp, which were acceptable.The customer sent two samples to be processed on the alternate platform and then compared the results to those obtained on the immulite 1000 instrument, which were reproducible.The cause of the discordant, falsely low afp results on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is needed.

Event Description

The customer obtained discordant, falsely low alfa-fetoprotein (afp) results on one patient sample upon initial and repeat testing on immulite 1000 instrument, when using reagent lot 210.The discordant results were reported to the physician(s), who questioned them.The sample was then sent to an alternate laboratory where it was tested on an alternate platform and the result was higher.The sample was sent to a 2nd alternate laboratory where it was tested on another immulite 1000 instrument, also resulting lower.The sample was then sent to a 3rd alternate laboratory where it was tested on an alternate platform and the result was higher.It is unknown if the corrected results from the alternate platforms were reported to the physician(s).There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely low afp results.

• Brand Name: IMMULITE / IMMULITE 1000 AFP
• Type of Device: IMMULITE / IMMULITE 1000 AFP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6344115
• MDR Text Key: 68137447
• Report Number: 2432235-2017-00134
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P010007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE / IMMULITE 1000 AFP
• Device Catalogue Number: LKAP
• Device Lot Number: 210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 52 YR