MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD IMMULITE 2000 AFP

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer reported depressed alpha fetoprotein (afp) results for a female patient's sample with the immulite 2000 xpi analyzer when compared to an alternate method.Siemens is investigating.Mdr 1219913-2021-00486 was filed for the discordant observation of 12-oct-2021 (atellica im analyzer), mdr 1219913-2021-00488 was filed for the discordant observation of 22-oct-2021 (atellica im analyzer) and mdr 1219913-2021-00491 was filed for the discordant observation of 27-oct-2021 (atellica im analyzer).
Event or Problem Description
The customer reported a discordant depressed alpha fetoprotein (afp) result for a female patient's sample with the immulite 2000 xpi afp.The patient sample was diluted and the diluted result was higher.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, immulite 2000 xpi afp results.
Additional Manufacturer Narrative
The initial mdr 1219913-2021-00487 was filed on november 19, 2021.Additional information - december 14, 2021: an outside the united states (ous) customer reported high results for afp, needed clarification as to why on one method the neat result reported greater linearity and one method reported on curve.In further review of this case, it is likely a hook sample that hooked back into the curve due to the high amount of afp antigen present.As per the interpretation of results section in the atellica im afp instructions for use 10995310_en rev.03, 2020-02, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." furthermore, as per the interpretation of results section instructions for use: "high afp concentrations can cause a paradoxical decrease in the rlus (high dose hook effect).In this assay, patient samples with afp concentrations above the measuring interval and as high as 1,000,000 ng/ml (830,000 iu/ml) will report >1,000.0 ng/ml (830.00 iu/ml).Results were established using the atellica im analyzer" there is insufficient sample to be sent in.The immulite and atellica im afp assays have no claim for correlation however, they do both have the same intended use.In house data was reviewed for atellica afp kit lot 238 and all release criteria was met.There has been no further request for technical assistance.No product nonconformance identified.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00486 supplemental 1, mdr 1219913-2021- 00488 supplemental 1 and mdr 1219913-2021-00491 supplemental 1 were filed for the same patient.

• Brand Name: IMMULITE 2000 AFP
• Common Device Name: IMMULITE 2000 AFP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.; glyn rhonwy; uk registration #: 3002806944; llamberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 12844271
• Report Number: 1219913-2021-00487
• Device Sequence Number: 4080881
• Product Code: LOK
• UDI-Device Identifier: 00630414961033
• UDI-Public: 00630414961033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381187
• Device Lot Number: 515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female