MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. MICROALBUMIN_2 REAGENTS (UALB)

Model Number MICROALBUMIN_2 REAGENTS (UALB)

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

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

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The quality controls were within range on the day of the event.The customer checked the sample and noted large bubbles.The customer then poured primary tube into a secondary cup and repeated the samples.A siemens headquarter support center (hsc) reviewed the instrument data and observed that the reaction curves are consistent with an interference in the patient samples.The cause of the discordant, falsely elevated ualb_2 results on one patient sample is due to sample specific interference.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated urine microalbumin 2 (ualb_2) results were obtained on one patient sample on two advia 2400 instruments (serial numbers (b)(4)).The discordant results were not reported to the physician(s).After auto-dilutions, the sample was rerun on both instruments, resulting lower.The customer re-spun the sample, performed manual dilution and reran the sample on advia 2400 instrument ((b)(4)), resulting lower than the initial discordant results.The corrected result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ualb_2 results.

• Brand Name: MICROALBUMIN_2 REAGENTS (UALB)
• Type of Device: MICROALBUMIN_2 REAGENTS (UALB)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6195153
• MDR Text Key: 63325882
• Report Number: 2432235-2016-00791
• Device Sequence Number: 1
• Product Code: JIR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROALBUMIN_2 REAGENTS (UALB)
• Device Lot Number: 373185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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
• Patient Sequence Number: 1