MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 UE3

Model Number IMMULITE 2000 UE3

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

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens customer service engineer (cse) and field application specialist (fas) were dispatched to the customer site.Siemens cse and fas analyzed the instrument and did not find any instrument malfunction.The cause of the discordant, falsely low ue3 results on patient samples is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

The customer obtained discordant, falsely low unconjugated estriol (ue3) results on patient samples on an immulite 2000 xpi instrument.The discordant results were reported to the physician(s), who questioned them.It is unknown if the samples were repeated and if the repeat results were reported to the physician(s).There was delay in reporting of results.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ue3 results and delay in reporting of results.

Manufacturer Narrative

The initial mdr 2247117-2017-00053 was filed on april 28, 2017.Additional information (06/27/2017): a siemens technical operations specialist reviewed the performance of two lots of quality control materials across immulite 2000 xpi unconjugated estriol kit lots 297 through 311.There was no significant change in performance of the two lots of quality control materials for levels 1 (average dose of 0.55 ng/ml), 2 (average dose of 2.25 ng/ml) and 3 (average dose of 7.0 ng/ml) across the different kit lots of immulite 2000 xpi unconjugated estriol.All mean values were within +/- 1sd from the target mean.The allowable tolerance is +/- 2sd.Data review from a reference panel that contains 7 samples covering dose values from 0.38 ng/ml to 9.5 ng/ml across immulite 2000 xpi unconjugated estriol kit lots 297 through 311 did not indicate any significant changes in performance across the different kit lots.The available adjustment slopes for immulite 2000 xpi unconjugated estriol kit lots 296 through 311 were evaluated.Review of the data shows that kit lots 296 through 311 did not exceed an adjustment slope of 1.25.The instrument parameter for the upper limit of the adjustment slope is 1.8.A lower bias was observed on a few kit lots, however, this bias does not exceed the expectation of the assay.No product deficiency has been noted.The cause of the low unconjugated estriol results with kit lot 306 is unknown.The device is performing within manufacturing specifications.No further evaluation of the device is required.

Manufacturer Narrative

Additional information (09/14/2017): the kit lot affected was 309.

• Brand Name: IMMULITE 2000 UE3
• Type of Device: IMMULITE 2000 UE3
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd NJ LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6530369
• MDR Text Key: 74153003
• Report Number: 2247117-2017-00053
• Device Sequence Number: 0
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 UE3
• Device Lot Number: 309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 06/27/2017; 09/14/2017
• Supplement Dates FDA Received: 07/20/2017; 09/15/2017
• 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