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

Model Number	33000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9680746-2023-00004
• Device Sequence Number: 14825514
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)230731(11)220731(10)272194
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K140496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown