MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	03L77-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated glucose results on the architect c16000 analyzer.The following data was provided: t0 169.1 mg/dl 92.1 mg/dl; t1 240.3 mg/dl 144 mg/dl; t2 216 mg/dl, 101.2 mg/dl.Due to imprecise glucose results, the doctor started a treatment based on the first result, which turned out to be inappropriate, causing significant hypoglycemia in the patient.No further details regarding the treatment or how the patient is doing, are yet available.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Several qc and patient results were flagged exp and ctrl (not valid).The issue was resolved by recalibrating the r1, r2 and sample pipettors and replacing a bent r1a reagent probe (list number 09d48-03).Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Additional Manufacturer Narrative
On (b)(6) 2019, the suspect medical device was changed from clinical chemistry glucose reagents ln 03l82-21 lot unknown, to the architect c16000 analyzer ln 03l77-01 sn (b)(4) both manufactured at the same site.An evaluation is still in process and a final report will be submitted when the evaluation is complete.

• Brand Name: ARCHITECT C16000 SYSTEM
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8090294
• Report Number: 1628664-2018-02026
• Device Sequence Number: 16159603
• Product Code: JJE
• UDI-Device Identifier: 00380740006006
• UDI-Public: 00380740006006
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 03/10/2019

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 Catalogue Number: 03L77-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/09/2019; 02/27/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/04/2019; 03/10/2019
• 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 C16000 ANALYZER; CLINICAL CHEMISTRY GLUCOSE REAGENTS; CLINICAL CHEMISTRY GLUCOSE REAGENTS; LN 03L77-01 SN (B)(4); LN 03L82-21 LOT UNKNOWN; LN 03L82-21 LOT UNKNOWN; ARCHITECT C16000 ANALYZER; LN 03L77-01, SN (B)(4)
• Outcome Attributed to Adverse Event: Other