MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I 25-OH VITAMIN D REAGENT KIT; SYSTEM, TEST, VITAMIN D

Model Number	08P4532
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a physician is questioning falsely depressed alinity i vitamin d results for a male patient who had been prescribed vitamin d supplements.The patient had multiple unnecessary lab tests and subsequent visits to sub-specialists due to "low vitamin d" in the setting of high dose vitamin d replacement.The patient also had additional visits to endocrinology and gi specialists, as well as a visit to the hospital.He also had an unnecessary endoscopy procedure to rule out mal-absorptive disorders causing low vitamin d despite therapy.The following data was provided (reference range for vitamin d 30 to 80 ng/ml): sid not provided result from (b)(6) 2021 ((b)(4)) 21 ng/ml; sid (b)(6) results from (b)(6) 2021 ((b)(4)) 13 ng/ml; sid (b)(6) result from (b)(6) 2021 ((b)(4)) 29 ng/ml; the medical provider sent a duplicate sample to (b)(6) on (b)(6) 2021 and the following data was provided: (b)(6) results d2: 27 ng/ml, d3: 61 ng/ml, total: 88 ng/ml.The patient had an unnecessary endoscopy procedure to rule out malabsorptive disorders causing low vitamin d despite therapy.
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Additional information was received from the customer indicating that the patient is 69 years old with a history of cardiomyopathy status post pacemaker placement, cerebrovascular incident, warfarin therapy, osteoporosis, and vitamin d deficiency.The outcome of the endoscopy was that the patient had a very benign upper endoscopy.No cause for his vitamin d deficiency or gi symptoms was observed.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.New information was received from the customer and added to field a2 age and b5.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, attached data, trending data, labelling, and device history records.Return testing was not completed as returns were not available.In-house testing was completed.The ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review determined no related trend for the issue for the product.Device history record review did not identify any issues associated with lot 19441ui00.Labelling was reviewed and found to adequately address the issue under review.A test protocol was completed using retained quality file samples and all acceptance criteria was met.As per product labelling, results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.If the 25-oh vitamin d results are inconsistent with clinical evidence, additional testing is recommended.When testing samples from patients whose predominant form of vitamin d is vitamin d2, such as patients receiving vitamin d2 supplementation, results that are subtherapeutic should be confirmed with another method, such as lc-ms/ms, before being used for patient management.Product labelling provides information on possible reasons for false depressed results and potentially interfering substances.Based on the investigation, no systemic issue or deficiency of the alinity i 25-oh vitamin d reagent lot 19441ui00 was identified.

• Brand Name: ALINITY I 25-OH VITAMIN D REAGENT KIT
• Common Device Name: SYSTEM, TEST, VITAMIN D
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11807443
• Report Number: 3005094123-2021-00088
• Device Sequence Number: 3535885
• Product Code: MRG
• UDI-Device Identifier: 00380740121952
• UDI-Public: 00380740121952
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: 08P4532
• Device Catalogue Number: 08P45-32
• Device Lot Number: 19441UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/18/2021; 07/13/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/07/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, AI02234; ALNTY I PROCESSING MODU, 03R65-01, AI02234; ALNTY I PROCESSING MODU, 03R65-01, AI02234; ALNTY I PROCESSING MODULE, 03R65-01, AI02232; ALNTY I PROCESSING MODULE, 03R65-01, AI02232; ALNTY I PROCESSING MODULE, 03R65-01, AI02232
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR