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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer obtained falsely elevated human chorionic gonadotropin (hcg) results on multiple patient samples using lot 466 on the immulite 2000 xpi instrument.Preventative maintenance was performed on the instrument.Additionally, the probe and dual resolution dilutors (drd) alignments and connections on the instrument were checked.A water test was also processed and a precision test was performed using patient samples.The probes were also cleaned and a system check was performed.Furthermore, the customer's handling of kits, adjustments, quality control material, and samples were also reviewed and the instrument was decontaminated.The instrument was performing within specifications.Siemens is investigating the issue.Mdrs: 1219913-2022-00061, 1219913-2022-00062, 1219913-2022-00063, 1219913-2022-00064, 1219913-2022-00065, 1219913-2022-00067 and 1219913-2022-00068 were filed for the same event.

Event Description

Falsely elevated human chorionic gonadotropin (hcg) results were obtained on four patient samples on immulite 2000 xpi instrument.The discordant results were not reported to the physician(s).Three samples were repeated on the same instrument, recovering falsely elevated.The samples were also repeated on an alternate (non-siemens) instrument.The results obtained on the alternate instrument recovered lower than the initial results.The repeat results from the alternate (non-siemens) instrument were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated hcg result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00066 on 21-feb-2022.Additional information (b)(6) 2022): siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated human chorionic gonadotropin (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 (b)(6) 2022, 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.The component code, type of investigation, investigation findings and investigation conclusion codes in section h6 and section h9 were updated based on the additional information.Mdrs 1219913-2022-00061_s1, 1219913-2022-00062_s1, 1219913-2022-00063_s1, 1219913-2022-00064_s1, 1219913-2022-00065_s1, 1219913-2022-00067_s1 and 1219913-2022-00068_s1 were filed for the same event.

• Brand Name: IMMULITE® 2000 HUMAN CHORIONIC GONADOTROPIN (HCG)
• Type of Device: IMMULITE® 2000 HUMAN CHORIONIC GONADOTROPIN (HCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy llanberis; gwynedd, LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy llanberis; uk registration #: 3002806944; gwynedd, LL554 EL; UK LL554EL
• Manufacturer Contact: kristin kehyaian ; 511 benedict avenue; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 13573535
• MDR Text Key: 288122024
• Report Number: 1219913-2022-00066
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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