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

Model Number 33000

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is case-(b)(4).The number of patients involved is unknown.The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access vitamin b12 reagents were not returned for evaluation.All assay and system verifications met specifications at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.Per the access vitamin b12 instructions for use p/n a98094, in expected results section it states: 2.Sera from 106 normal subjects and 60 diagnosed vitamin b12 deficient patients were assayed to establish expected ranges.The diagnosis of vitamin b12 deficiency was based on mean corpuscular volume, hematocrit, the presence of megaloblastic cells in bone marrow aspirates, and by vitamin b12 ria.A non-parametric estimate at the 95% confidence level yields the following ranges: the deficient range is = 145 pg/ml.Our bec application technical specialist for vitamin b12 assay sent the instructions for use to the customer and sent the access method comparison study between the dxi instrument and the siemens centaur instrument.He noted the customer¿s reference range for the dxi instrument was set to 250-1100 pg/ml whereas the reference range for the centaur instrument was set to 200-1100 pg/ml.He explained the access ifu has a deficiency cut off at 145 pg/ml and for the five (5) patients sent for review by the customer, all 5 results are concordant between dxi and centaur when a cut off of 145 pg/ml is used for dxi.The access vitamin b12 is expected to run lower than competitor¿s assays.The comparison method study shows an overall bias of -37% when the dxi is compared to centaur, this is consistent with the data provided by the customer.In conclusion, the cause of this event is likely a use error by not following the vitamin b12 instructions for use.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

Event Description

On (b)(6) 2021, the customer reported obtaining erroneously low access vitamin b12 results since month of august for several patients involving the laboratory's unicel dxi 800 access immuno analyzer serial number (b)(4).The customer stated the pathologist was questioning the low b12 results and they sent out the samples to another lab (quest) where they have been tested on the siemens centaur method.The siemens centaur results were 100 units (or more) higher than the access vitamin b12 results.Per the customer, the pathologist is concerned by the results below 200.The customer only provided vitamin b12 results for five (5) patients: 1 patient (collected on (b)(6) 2021) with dxi result at 146 pg/ml obtained on centaur at 401 pg/ml.1 patient (collected on (b)(6) 2021) with dxi result at 189 pg/ml obtained on centaur at 391 pg/ml.1 patient (collected on (b)(6) 2021) with dxi result at 167 pg/ml and at 303 pg/ml on centaur.1 patient (collected on (b)(6) 2021) with dxi result at 302 pg/ml and at 514 pg/ml on centaur.1 patient (collected on (b)(6) 2021) with dxi result at 189 pg/ml and at 329 pg/ml on centaur.The customer reported that the doctor has been given b12 supplements based on the low access vitamin b12 results.No further changes in patient treatment were reported.It is unknown how many patients are affected.It is unknown if the five (5) patients results given as example were affected by the supplementation in vitamin b12.No hardware errors or issues with other assays were reported in conjunction with this event.No system check data provided.The customer stated the 10 000 tests maintenance was done two weeks ago.Calibration passed on 19jul2021 and on 9aug2021 with reagent lot 124295 and calibrator lot 922968.A second calibration passed on 16sep2021 with reagent lot 922969 and calibrator lot 922968.Qc level 1 was passing within the laboratory¿s established ranges even if a value was outside low of the 2sd ranges, it was repeated within ranges on 5sep2021.Qc level 3 was passing within ranges, one value was outside low of the 2sd ranges on 19sep2021, it was repeated within ranges at same date.The customer stated the cap surveys were passing.Sample tube collection type was becton dickinson gold top tubes.The customer reported that the sample was centrifuged at 3400 rpm for 10 minutes.Samples were clear and not hemolyzed.No further sample information was provided.

• Brand Name: ACCESS VITAMIN B12 COBALAMIN
• 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
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12622657
• MDR Text Key: 276109703
• Report Number: 2122870-2021-00163
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)211231(11)201231(10)922969
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2021

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 Expiration Date: 12/31/2021
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 922969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/27/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2020
• 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