MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 1000 BR-MA

Model Number IMMULITE 1000

Device Problems High Test Results (2457); Device Ingredient or Reagent Problem (2910)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Discordant, falsely elevated cancer antigen 15-3 (ca 15-3) results were obtained on three patient samples on an immulite 1000 instrument using lot 302.The discordant results for samples 34 and 1128 were not reported to the physician(s), while the discordant result for patient 3 was reported to the physician(s).Sample 1128 was repeated on the immulite instrument, resulting higher than the initial result.All three samples were tested on an alternate platform, resulting lower.The repeat results for samples 34 and 1128 from an alternate platform were reported to the physician(s).It is unknown if the repeat results for patient 3 was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca 15-3 results.

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the quality control (qc) adjustment data and indicated that the adjustment showed a high coefficient of variance (cv) with the low adjustor.The cvs were out of the manufacturing ranges.The cause of the discordant, falsely elevated ca 15-3 results on three patient samples was related to the high cvs.

Manufacturer Narrative

The initial mdr 2432235-2015-00324 was filed on july 10, 2015.The first supplemental mdr 2432235-2015-00324_s1 was filed on july 24, 2015.Additional information (10/28/2015): after multiple attempts, no further information could be obtained from the customer.The cause of the discordant, falsely elevated ca 15-3 results on three patient samples was consistent with a site specific reagent issue.

Manufacturer Narrative

Corrected information (06/14/2015): the initial mdr was filed with a date of 06/15/2015.The correct date is 06/14/2015.This has been corrected.

• Brand Name: IMMULITE 1000 BR-MA
• Type of Device: IMMULITE 1000 BR-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; reg # 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; reg # 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 4906915
• MDR Text Key: 6837024
• Report Number: 2432235-2015-00324
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: BK
• PMA/PMN Number: K013984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 1000
• Device Catalogue Number: LKBR
• Device Lot Number: 302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2015; 10/28/2015
• 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: Reuse
• Patient Sequence Number: 1