MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HCG

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause for the low hcg results.The limitations section of the instructions for use states: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.[see boscato lm, stuart mc.Heterophilic antibodies: a problem for all immunoassays.Clin chem 1988:34: 27-33.] samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur.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.".

Event Description

The customer reported discordant negative hcg results on the immulite 2000 xpi for a patient where a low positive result was expected.There are no reports that treatment was altered or prescribed or adverse health consequences due to the negative immulite 2000 xpi hcg results or due to the delay in reporting results due to the repeat testing.

Manufacturer Narrative

Siemens filed mdr 1219913-2020-00154 on june 22, 2020 for discordant negative hcg results on the immulite 2000 xpi for a patient where a low positive result was expected.Additional information - june 23, 2020.The customer reported that the sample was tested on the advia centaur and the results were negative.Additional information - july 2, 2020 the customer provided the following information: immulite 2000 1: acc.Num 53213865= 1.49, 1.07, 5.8, 4.26, 3.78 ,5.18 ,4.07, >1.(results reported in initial mdr.).Immulite 2000 1: acc.Num 53213721 (same patient, redrawn)= 8.99, 1.29, 10.1, 2.78, >1, 5.59, 7.54, >1, >1.Immulite 2000 2: acc num 53213721 = same results as immulite 2000 1.Advia centaur thcg: acc.Num.53213865 = <0.00, <0.00, <0.00.Siemens reviewed the additional information provided on july 2, 2020.The patient results on immulite 2000 #1 show some imprecision especially on the 2nd patient draw (results range from 1-10.1 miu/ml).Siemens continues to investigate.

Manufacturer Narrative

Siemens filed mdr on (b)(6), 2020 for discordant negative hcg results on the immulite 2000 xpi for a patient where a low positive result was expected.Mdr supplemental 1 was filed on (b)(6), 2020 with additional information.On (b)(6), 2020 additional information: a hcg precision study was performed on the instrument and the following results were obtained: qc level 1: mean= 6.43 ; cv= 7.73% ; n= 5.Qc level 2: mean= 34.6 ; cv= 2.51% ; n= 5.Qc level 3: mean= 516 ; cv= 3.40% ; n= 5.The medication list, certralin, maxitrol, neorastin, teglex, cysplatine, etaposide, was reviewed.The medications are used in treating cancer patients and have not been tested by siemens with the immulite 2000 hcg assay.The issue being reported appears to be isolated to a patient but gender and clinical information are not available.The immulite 2000 hcg assay is intended to aid in the detection of pregnancy.Siemens continues to investigate and has asked for additional information from the customer.

Manufacturer Narrative

Siemens filed mdr 1219913-2020-00154 on june 22, 2020 for discordant negative hcg results on the immulite 2000 xpi for a patient where a low positive result was expected.Mdr 1219913-2020-00154 supplemental 1 was filed on july 14, 2020 and mdr 1219913-2020-00154 supplemental 2 was filed on october 2, 2020 with additional information.November 2, 2020 additional information: the customer reported discordant patient results with immulite 2000 xpi hcg assay.On (b)(6) 2020, a patient sample was tested multiple times with hcg results ranging from <1 to 5.58 miu/ml.The same sample was also tested on an alternate method (advia centaur) and it resulted negative for pregnancy.The gender, age and clinical status of this patient is unknown.The physician asked siemens for any information related to potential impact with the immulite 2000 hcg assay and the medications certralin, maxitrol, neorastin, teglex, cysplatine and etaposide.These medications are used in treating cancer patients, and have not been tested by siemens and are not listed in the immulite 2000 hcg instructions for use specificity table.The immulite 2000 hcg assay is intended to aid in the detection of pregnancy.The customer has no plans of redrawing and repeating testing of this patient on the immulite 2000 hcg assay.Hcg precision was evaluated at the customer site by running qc levels 1-3 in replicates of 5 and results meet ifu precision limits.A potential product issue has not been identified.The customer is operational at this time.No further investigation is required.The codes in section h6 have been updated.

• Brand Name: IMMULITE 2000 XPI HCG
• Type of Device: HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL,; UK LL55 4EL,
• MDR Report Key: 10182099
• MDR Text Key: 232759938
• Report Number: 1219913-2020-00154
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00063041496113
• UDI-Public: 0063041496113
• Combination Product (y/n): N
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1