MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT IGENTAMICIN

Catalog Number	01P31-25
Medical Device Problem Codes	Leak/Splash (1354); Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	11/05/2019
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.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported that when taking out the architect gentamicin container from the analyzer there was a "small explosion/popping noise".The technician saw vapor/smoke without any smell coming from the container.A few seconds later, the technician realized that she had a splash on the outer part of her left wrist, and it was a little irritated, and on the ring finger of her right hand she felt something like a kind of embedded splinter.The affected areas were washed but no additional medical intervention was sought.There was no adverse impact to patient management, user safety, or facility damage reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 04281be00, and no trends have been identified for the issue.The returned kit showed no atypical appearance of the liquids / septum, or indication that an explosion occurred.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the safety data sheet of the architect igentamicin reagents and the architect systems operations manual concluded that the issue is sufficiently addressed.According to the safety data sheet the architect igentamicin microparticles do not present an explosion hazard.Based on the investigation no product deficiency was identified for the architect igentamicin reagent lot number 04281be00.

• Brand Name: ARCHITECT IGENTAMICIN
• Common Device Name: GENTAMICIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9384445
• Report Number: 3002809144-2019-00983
• Device Sequence Number: 585489
• Product Code: LCD
• UDI-Device Identifier: 00380740001742
• UDI-Public: 00380740001742
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: 01P31-25
• Device Lot Number: 04281BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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, LN 03M74-95,; ARCHITECT I2000SR ANALYZER, LN 03M74-95,; SERIAL # (B)(4); SERIAL # (B)(4)