MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CMV IGM

Model Number IMMULITE 2000 CMV IGM

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed increased imprecision on some patient samples with the immulite®/immulite® 1000 cmv igm reagent lots 330 and 331 and on the immulite® 2000 / immulite® 2000 lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, and 267.These samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across nonreactive, indeterminate, and reactive ratios.Quality controls provided in the cmv igm kit may not detect the imprecision with patient results.An urgent field safety notice (ufsn) imc 16-22a.Ous was sent out to customers and an urgent medical device recall (umdr) imc16-22.A.Us was sent to us customers in august 2016.The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lots listed above.Siemens recommends transitioning to immulite 2000/2000 xpi cmv igm kit lots 268 and above and immulite 1000 kit lot 332 and above.

Event Description

A discordant, false reactive igm antibodies to cytomegalovirus (cmv igm) result was obtained on one patient sample on an immulite 2000 instrument when using kit lot 263.The customer had collected two sample tubes from the patient.The discordant result was reported to the physician(s), who questioned it.A new sample was obtained from the patient and was tested on the same instrument, resulting non-reactive.The new draw was repeated, also resulting non-reactive.The customer then repeated the original sample (tube 1), which resulted non-reactive.The customer pulled a different tube obtained from the patient of the original sample draw (tube 2) and ran it on the same instrument, resulting non-reactive.The corrected non-reactive results were reported to the physician(s).There were no reports of patient intervention or adverse health consequences due to the discordant, false reactive cmv igm result.

• Brand Name: IMMULITE 2000 CMV IGM
• Type of Device: IMMULITE 2000 CMV IGM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 5957049
• MDR Text Key: 55004372
• Report Number: 2432235-2016-00564
• Device Sequence Number: 1
• Product Code: LKQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 CMV IGM
• Device Catalogue Number: L2KCM
• Device Lot Number: 263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• 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
• Removal/Correction Number: 2432235-08/31/2016-001-R
• Patient Sequence Number: 1