MAUDE Adverse Event Report: BECKMAN COULTER ACCESS B12 REAGENT; RADIOASSAY, VITAMIN B12

Catalog Number	33000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not supply patient demographic information such as the patient's exact date of birth and weight.Initial customer's phone is (b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to verify instrument peformance as there were no hardware errors in conjunction with this event.There is no indication that the customer sent the access b12 reagent to bec for further evaluation.The customer has not sent any patient sample to bec for testing to date.There were no errors, system flags or event log messages in conjunction with this event.In conclusion, the cause of the reproducible, normal access b12 results could not be determined with the information provided.
Event or Problem Description
The customer reported obtaining reproducible, normal vitamin b12 (access b12) results for one (1) patient since (b)(6) 2016 on the laboratory's unicel dxi 600 access immunoassay system serial number (b)(4).On (b)(6) 2016 the customer obtained an access b12 result within the normal reference range of the assay for the patient.This sample was then sent to a reference laboratory and tested on an alternate methodology (roche elecsys) which produced a discordant result below the normal reference range of the assay.The normal access b12 results were released from the laboratory.There was a change in patient management in conjunction with the normal access b12 results as the patient's vitamin b12 treatments were delayed until after receiving the roche result in (b)(6) of 2016.System verification parameters such as qc (quality controls), calibrations and system checks were performing within assay and laboratory specifications at the time of the event.There were no reports of issues with other analytes, samples or the hardware in conjunction with this event.The patient's sample was collected in a 5 ml (milliliter) serum tube with a gel separator which was centrifuged for ten (10) minutes at 3,000 rpm (revolutions per minute) at room temperature.There were no reports of any sample integrity issues in conjunction with this event.
Additional Manufacturer Narrative
The customer provided one (1) patient sample for interference testing to the beckman coulter (bec) marseilles complaint handling unit (chu).The patient's sample was first tested neat and recovered with an access b12 result within normal reference range of the assay.This result confirmed the reproducible normal results obtained by the customer.Dilution testing was then performed which resulted with non-linear results.Interference testing, using a mix of different blockers including alkaline phosphatase, was then performed.The result of the interference testing did not lower the signal of the patient's sample.This type of interference could not be determined.In conclusion, the investigation demonstrated that some form of unknown interference is the cause of the reproducible normal access b12 results as dilution testing produced non-linear results.

• Brand Name: ACCESS B12 REAGENT
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6307348
• Report Number: 2122870-2017-00006
• Device Sequence Number: 1251381
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)170731(11)160830(10)671102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 33000
• Device Lot Number: 671102
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR