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

Catalog Number 33000

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is case:(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.Reagent lot was not supplied as the event was too old for data recovery.Unable to obtain actual reagent manufacture date and to generate reagent udi.No hardware issues or other assay issues were reported in conjunction with this event by the customer.No issues with sample integrity were reported by the customer.No calibration, system check or quality control data was provided.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.Although the exact cause of this event cannot be determined, an interference due to a high concentration of intrinsic factor antibodies in patient sample is suspected.Per the vitamin b12 instructions for use, part number a89094 l, ¿approximately 50% of patients with pernicious anemia have intrinsic factor antibodies.The initial denaturation step in the access vitamin b12 assay inactivates intrinsic factor blocking antibodies.However, in very rare cases, some samples may not be inactivated due to the heterogeneity or extremely high titer of the intrinsic factor antibodies.Such interfering antibodies may cause erroneous results.Patients should be further evaluated if suspected of having these antibodies or if the vitamin b12 results are in conflict with other clinical or laboratory findings.¿ the customer acknowledged that the other haematology results (haemoglobin, platelets, mcv, etc.) in conjunction with a ¿normal¿ b12 should have indicated something other than cancer could be the case.The customer does not use beckman coulter haematology instrumentation or remisol to review haematology alongside the haematinics from the dxi.There was no algorithm setup to help flag a potential issue prior to results leaving the laboratory.The root cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2020, the customer reported obtaining normal vitamin b12 results instead of low results for one patient involving the laboratory's dxi 800 access immunoassay analyzer (serial number (b)(4)).Between january 2010 and july 2017, all vitamin b12 results, haematinics (hb) and full blood count (fbc) tests were within normal reference range.On (b)(6) 2017, vitamin b12 was 894 ng/l.[fbc was normal, hb was 131 g/l.Mean corpuscular volume (mcv) had increased to 99 fl].On (b)(6) 2018, no vitamin b12 test performed.[hb had fallen to 111g/l.Mcv was 113fl and mean corpuscular hemoglobin (mch) was 39.2pg].On (b)(6) 2018, vitamin b12 was 611 ng/l.[hb had fallen to 88g/l, plts 110, mcv 122 fl, mch 45.4pg].On (b)(6) 2019 the vitamin b12 result was 289 ng/l.On (b)(6) 2019 the vitamin b12 result was 325 ng/l.On (b)(6) 2019 the vitamin b12 result was 167 ng/l.On (b)(6) 2020 the vitamin b12 result was 119 ng/l (result not questioned).This triggered the reflex ifab test which was positive (no data provided) and the customer suspected an ifab interference at that time for the previous higher results obtained.The access vitamin b12 reference range is 180 - 914 pg/ml.The customer reported that there was a delay in the diagnosis of pernicious anemia for one patient as a consequence of the erroneous access vitamin b12 results.The patient presented with pancytopenia and myelodysplastic syndromes which was initially thought to be the underlying cause as opposed to pernicious anemia.The patient received 18 months of chemotherapy because of the elevated access b12 results.No issues with sample integrity were reported by the customer.No hardware errors or other assay issues were reported in conjunction with this event.Customer did not provide any data and the issue was too old for data recovery.Unable to generate reagent udi.Sample information such as sample collection tube used, centrifugation time an speed, storage or handling was not provided by the customer.

• Brand Name: ACCESS VITAMIN B12 REAGENT
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10239835
• MDR Text Key: 204409449
• Report Number: 2122870-2020-00063
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/22/2020
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1900
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other