MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INTACT PTH REAGENT KIT; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number 08P31-24

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

The customer reported falsely elevated alinity i intact pth results generated on the alinity i processing module for a 48-year-old patient who has two thyroid nodules and undergoing treatment with levothyroxine, calcium, and vitamin d 25 oh.The patient was considered under control until (b)(6) 2022 when the intact pth levels started increasing.Due to the increased results, the patient underwent additional testing which included scintigraphy, choline pet, ct scan of the abdomen and chest, all with iv contrast administered, and no abnormalities were found.The customer is not aware of any adverse effect on the patient from the procedures.Since the results were not consistent with the clinical findings, the physician suggested that the test be performed at a different laboratory.The patient was tested at two different laboratories and the results were within the normal range.The following data was provided: (b)(6) 2024 result = 155.7 pg/ml, (b)(6) 2023 result = 147.0 pg/ml, (b)(6) 2023 result = 130.3 pg/ml, (b)(6) 2023 result = 138.5 pg/ml, (b)(6) 2022 result = 132.9 pg/ml, (b)(6) 2022 result = 127.9 pg/ml, (b)(6) 2021result = 68.9 pg/ml, (b)(6) 2021 result = 61.2 pg/ml, (b)(6) 2020 result = 84.6 pg/ml, (b)(6) 2020 result = 97.7 pg/ml, and (b)(6) 2019 result = 77.8 pg/ml.(b)(6) 2024 laboratory # 1 (chemiluminescence method) pth result = 29.2 pg/ml reference range: 18.4 to 88.0 pg/ml.(b)(6) 2024 laboratory # 2 (electrochemiluminescent immunoassay method) pth result = 34.9 pg/ml reference range: 14.90 to 56.90 pg/ml.Update: on 27feb2024, the customer provided additional information.The sample id processed on (b)(6) 2024 was (b)(6).The customer requested for more samples from the patient and tested them on various platforms.The following data was provided: (b)(6) 2024 sid (b)(6); alinity i intact pth result from edta tube = 138.79 pg/ml.Alinity i intact pth result from lithium heparin tube = 150.75 pg/ml.Alinity i intact pth result from sodium heparin tube = 150.30 pg/ml.Alinity i intact pth result from yellow cap tube = 143.86 pg/ml.One of the samples from (b)(6) 2024 was sent to another lab with the architect platform and the result was 134.40 pg/ml.Another sample from (b)(6) 2024 was processed on the roche platform and the result was 34.80 pg/ml (reference range: 15 to 65 pg/ml).There was no further impact to patient management reported.

Manufacturer Narrative

Section a1 - patient identifier: sids = (b)(6).This report is being filed on an international product, alinity i intact pth, list number 08p31-24, that has a similar product distributed in the us, list number 08p31-21/-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Section a3a - sex: updated to female.Section b5 - describe event or problem: updated with additional information provided by the customer.Section d4 - lot #: was corrected from 1539l823 to 01539l823.Section d4 - primary udi number: was corrected from (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

Update: on (b)(6) 2024, the customer provided additional information on the patient.The patient is female.(b)(6) 2024 pth result = 155.7 pg/ml (date was correct to (b)(6) 2024); calcium result = 8.8 mg/dl.(b)(6) 2023 pth result = 147.0 pg/ml; calcium result = 9.26 mg/dl.(b)(6) 2023 pth result = 130.3 pg/ml; calcium result = 9.94 mg/dl.(b)(6) 2023 pth result = 112.7 pg/ml.(b)(6) 2023 pth result = 138.5 pg/ml.(b)(6) 2022 pth result = 132.9 pg/ml; 9.74 mg/dl.(b)(6) 2022 pth result = 127.9 pg/ml.(b)(6) 2021 pth result = 68.9 pg/ml; calcium result = 9.63 mg/dl.(b)(6) 2021 pth result = 61.2 pg/ml.(b)(6) 2020 pth result = 84.6 pg/ml; calcium result = 10.07 mg/dl.(b)(6) 2020 pth result = 97.7 pg/ml; calcium result = 9.5 mg/dl.(b)(6) 2019 pth result = 77.8 pg/ml.Consultation date: (b)(6) 2023.The following notations were noted: parathyroid scintigraphy: no evidence of adenoma.Thyroid scintigraphy: normal uptake of gland without cold nodules.Blood test on (b)(6) 2022: pth = 132.9 pg/ml; calcium = 9.74 mg/dl; tsh = 2.76.Current treatment: eutirox 50 mcg per day, spironolactone 100 mg every 2 days, vitamin d 4000 u every 2 days for two months.Consultation date: (b)(6) 2023 the following notations were noted: reason for the consultation: hyperparathyroidism, hypothyroidism, thyroid nodules, vitamin d insufficiency.Parathyroid choline pet ct: negative for hyperfunctioning tissue.Blood test on (b)(6) 2023: pth = 112.7 pg/ml; tsh = 1.52; ft4 = 0.98; vitamin d 35.8.Treatment: eutirox 10 mcg per day, spironolactone 100 mg per day, magnesium.Consultation date: (b)(6) 2023.The following notations were noted: reason for the consultation: hyperparathyroidism, hypothyroidism, thyroid nodules, vitamin d insufficiency.Treatment: eutirox 50 mcg per day, sporadic magnesium.Blood test on (b)(6) 2023: pth = 130.3 pg/ml; anti-thyroglobulin antibodies = 0.82; anti-tpo.Antibodies = 0.85; vitamin d = 43.3; calcium = 9.94; tsh = 1.89; ft4 = 0.92.Choline pet ct performed on (b)(6) 2023: no evidence of hyperfunctional parathyroid tissue.Thyroid ultrasound with doppler ((b)(6) 2023): thyroid and extrathyroid nodules with no major changes compared to previous tests.Blood test on (b)(6) 2023: pth = 147.0 pg/ml; vitamin d = 40.3; tsh = 2.45; ft4=0.92; calcium = 9.26 mg/dl.(b)(6) 2024 computed ct scan of the abdomen and pelvis (contrast medium: 63cc from xenetix, 225cc from e-z-cat).Findings: minimal fatty liver component, no lymph node clusters or masses seen, retroperitoneum clear.(b)(6) 2024 computed chest ct scan (contrast medium: 63 cc from xenetix).Findings: chest ct scan in the normal range, small reactive nodes in the anterior and middle mediastinum described, no focal lesion of the lung parenchyma.There was no further impact to patient management reported.

• Brand Name: ALINITY I INTACT PTH REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18816717
• MDR Text Key: 336737258
• Report Number: 3002809144-2024-00054
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P31-24
• Device Lot Number: 1539L823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female