MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS VITAMIN B12 COBALAMIN; RADIOASSAY, VITAMIN B12

Model Number 33000

Device Problem Low Test Results (2458)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2023

Event Type  Injury  

Event Description

On 26mar2023 the customer reported obtaining erroneous low b12 (access b12, part number 33000 and lot number 272194) result of 0 pg/ml was obtained on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) for one patient.The customer repeated the patient sample and obtained the same value of 0 pg/ml.There was a report of change to patient treatment which occurred in connection with this event.The customer reported the patient was administered a vitamin b12 shot (dose not provided).The patient was redrawn and retested for b12 the following day and a result of >1504 pg/ml (over range flagged) was obtained.There is no further report of change to patient treatment or management or patient injury.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check and calibration were passing within specifications at the time of the event.The customer does not perform quality control (qc) testing; therefore, there are no qc results for review.Sample collection and processing information such as sample type, volume collected, centrifugation time and speed and other sample handling information was not provided by the customer.

Manufacturer Narrative

Full patient identifier is (b)(6).Customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access vitamin b12 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check and calibration were passing within specifications at the time of the event.As customer did not perform qc testing, qc trends were not provided for review.In conclusion, the cause of this event cannot be determined with the available information.

• Brand Name: ACCESS VITAMIN B12 COBALAMIN
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills; clare ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills; clare ; EI
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16644196
• MDR Text Key: 312331320
• Report Number: 9680746-2023-00004
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)230731(11)220731(10)272194
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

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: 07/31/2023
• Device Model Number: 33000
• Device Catalogue Number: 33000
• Device Lot Number: 272194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• 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