MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT INTACT PTH; INTACT PARATHYROID HORMONE

Catalog Number	08K25-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a falsely elevated architect intact pth (ipth) result of >3000 pg/ml was generated for a (b)(6) year old female patient on (b)(6) 2018.The result was reported by the technician without retesting to confirm the elevated result.The result was questioned by the clinician because it did not match the clinical picture.The patient was redrawn on (b)(6) 2018 and the architect intact pth result was 74.8 pg/ml.The sample from (b)(6) 2018 was then retested generating a result of 73.4 pg/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Based on the available information, no product deficiency was identified.

• Brand Name: ARCHITECT INTACT PTH
• Common Device Name: INTACT PARATHYROID HORMONE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8105886
• Report Number: 3002809144-2018-00527
• Device Sequence Number: 1997940
• Product Code: CEW
• UDI-Device Identifier: 00380740048471
• UDI-Public: 00380740048471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2019
• Device Catalogue Number: 08K25-20
• Device Lot Number: 02818D000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/31/2018
• 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: ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4)