MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG); IMMULITE 2000 HCG

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

The customer reported imprecision for a patient sample with immulite 2000 hcg.The initial result was reported to the physician(s); however, it is unknown if the result was questioned.There are no reports that treatment was altered or prescribed or adverse health consequences due to the imprecision of the immulite 2000 hcg results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the customer care center (ccc) and reported imprecision on a patient sample using the immulite 2000 xpi human chorionic gonadotropin (hcg) assay.The spyfiles, maindata, daily events and errorlog were received and are under review.Siemens healthcare diagnostics is investigating the cause of the event.The limitations section of the instructions for use states the following: "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings.".

Manufacturer Narrative

The initial mdr 1219913-2021-00028 was filed on january 21, 2022.Additional information - january 26, 2022 the lot number and expiration date were unknown when the initial mdr was filed.This information has been added to section d4.An outside the united states (ous) customer reported immulite 2000/xpi hcg non-reproducible patient results.The initial patient result is often higher than clinically expected and repeat of the same sample on the same system is lower and in alignment with clinical expectation.This customer has not reported any concerns with immulite 2000/xpi hcg adjustment and/or quality control (qc) performance.Hcg within run precision has been verified and preanalytic's have been investigated at this customer site.Siemens continues to investigate.

Manufacturer Narrative

The initial mdr 1219913-2022-00028, was filed on 21 january 2022 and mdr 1219913-2022-00028 supplemental 1 was filed on 19 february 2022.17 march 2022 - correction: in mdr 1219913-2022-00028 supplemental 1, section b4 (date of this report) was listed as 18 february 2022, however the report was filed on 19 february 2022.22 february 2022 - additional information: siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated hcg results due to sample carryover.This can be observed when a sample is assayed for hcg immediately after an undiluted sample with a hcg value of >5000 miu/ml.This issue impacts serum and urine patient samples, as well as quality control samples and adjustors.The effect of carryover varies based on the concentration of the high hcg sample.Starting 2022-02-22 an urgent medical device correction (umdc, letter imc22-04.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter imc22-04.A.Ous) was sent to outside the us (ous).The umdc and ufsn explain the potential for carryover from high hcg samples into the next sample assayed for hcg on the immulite 2000/immulite 2000 xpi, and provides instructions to the customers.

• Brand Name: IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG)
• Type of Device: IMMULITE 2000 HCG
• 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; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney st; e. walpole, MA 02032 ; 3392064073
• MDR Report Key: 13321859
• MDR Text Key: 284888479
• Report Number: 1219913-2022-00028
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: 463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2432235-03/04/2022-002-C
• Patient Sequence Number: 1