MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2017
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 decreased clinical chemistry calcium results.The customer provided the following results (customer provided range 8.3-10.0): pt identifier: (b)(6), initial 0.8 mmol/l, retested on a different analyzer: 2.25 mmol/l.The results were not reported from the laboratory.There was no impact to patient management reported.
Additional Manufacturer Narrative
It was identified that the suspect device manufacture location was incorrectly documented in the initial manufacture report.All additional information relating to this event including evaluation will be documented in manufacture report number 1628664-2017-00267.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6572246
• Report Number: 1415939-2017-00110
• Device Sequence Number: 18854543
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: (01)00380740005948(17)171219(10)36253UN16
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 03L79-31
• Device Lot Number: 36253UN16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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: LN 03L77-01, C1601197