MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 1800 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number	07H77-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.An evaluation is in process.
Event or Problem Description
The customer observed falsely low hemoglobin (hgb) results for one patient that was generated using the cell-dyn 1800 analyzer.The following data was provided.Sid (b)(6) initial 7.2 (normal range 14 to 18 g/dl) due to the initial low result, the patient was referred to the hospital.Repeat using cell-dyn emerald analyzer (unknown serial number) at the hospital facility 8.1 (normal range (13.0 to 16 g/dl).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation 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 a review of instrument service.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation, the analyzer performed as intended and no product deficiency was identified.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product deficiency was identified.

• Brand Name: CELL-DYN 1800 ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6018340
• Report Number: 2919069-2016-02156
• Device Sequence Number: 19195328
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K030513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2017

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 Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 11/08/2016; 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1