MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N ANTISERUM TO HUMAN ALBUMIN

Model Number N ANTISERUM TO HUMAN ALBUMIN

Device Problem High Test Results (2457)

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

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that they observed a difference in albumin/csf results from two different dilutions on a patient sample on the atellica neph 630 system.Siemens analyzed the provided customer save data file.Siemens determined that there was no instrument or reagent malfunction.Albumin in serum and csf can also be analyzed using a single reference curve, provided that the appropriate sample dilution is selected manually.If the results obtained are outside the measuring range, the assay can be repeated using a higher or lower dilution of the sample as per the system's instruction manual.The customer diluted affected samples with nacl.The cause of the discordant albumin result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00044 was filed for the same event.

Event Description

Customer observed a difference between two diluted results from the same cerebral spinal fluid (csf) sample on the atellica neph 630 system using the n antiserum to albumin reagent (lot 153939b) on two separate dates.The original sample result was flagged for turbidity for immunoglobulin g (igg) and carried no flag for albumin.The initial albumin resulted in a value greater than the measuring range with an initial dilution of 1:5, the sample was repeated with a dilution of 1.2 and yielded lower values.The same sample was repeated two days later using the same instrument and reagent in 1:2 manual dilution with sodium chloride (nacl), which resulted in a lower value.The customer did not report any of the results obtained for this sample to the physician because the correct result is unknown.There are no known reports of patient intervention or adverse event due to the elevated albumin results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00043 on 18-apr-2019.Additional information (26-apr-2019): siemens headquarters support center (hsc) analyzed submitted atellica neph 630 save data file and determined that there was no indication of an instrument nor a reagent malfunction.Each urine and cerebral spinal fluid (csf) sample must be centrifuged prior to testing.Serum and plasma samples are automatically diluted 1:400 with n diluent and measured.Albumin in serum and csf can also be analyzed using a single reference curve, provided that the appropriate sample dilution is selected manually.The diluted samples must be measured within four hours.If the results obtained are outside the measuring range, the assay can be repeated using a higher or lower dilution of the sample.The cause of the discordant falsely, elevated albumin result is due to the user not following the instructions for use (ifu) of n antiserum to human albumin and igg.The related chapter, "assay of specimen", instructs the user to dilute specimens with n diluent.The customer used sodium chloride (nacl).The system is working according the specifications.The conclusion code was updated to reflect the additional information.Supplemental mdr 9610806-2019-00044_s1 was filed for the same event.

• Brand Name: N ANTISERUM TO HUMAN ALBUMIN
• Type of Device: N ANTISERUM TO HUMAN ALBUMIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8528751
• MDR Text Key: 142666395
• Report Number: 9610806-2019-00043
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): N
• PMA/PMN Number: K972929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: N ANTISERUM TO HUMAN ALBUMIN
• Device Catalogue Number: 10446282
• Device Lot Number: 153939B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1