MAUDE Adverse Event Report: BIOMERIEUX, SA API® RAPID 20 E; API® RAPID 20 E STRIP

Catalog Number	20701
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
An industry customer from (b)(6) reported a misidentification of serratia marcescens as serratia liquefaciens when testing a qc strain with api® rapid 20 e 25strips (ref.20701) - lot 1005589130.The customer stated they tested a known serratia marcescens strain and received an identification of 95.5% s.Liquefaciens (and 3.9% s.Marcenscens).The customer also used sequencing on this strain to obtain a phylogenetic tree.The sequencing confirmed that the strain was not s.Liquefaciens.The customer then repeated the rapid 20 e test and obtained serratia marcescens.There was no patient involved as this event pertains to an industry qc.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification by an industry customer in germany of a misidentification of serratia marcescens as serratia liquefaciens when testing a qc strain with api® rapid 20 e 25strips (ref.20701) - lot 1005589130.The customer stated they tested a known serratia marcescens strain and received an identification of 95.5% s.Liquefaciens (and 3.9% s.Marcenscens).Sequencing methodology confirmed the species serratia marcescens.Biomérieux internal investigation was conducted.Review of the complaint identified: the tested strain was obtained from a contamination.The customer does not test the recommended strains for qc.The customer performed retest with another rapid 20 e lot number 1006885690.Expiration date 22-apr-2020 and obtained a good identification to serratia marcescens.Complaints trend analysis identified one other complaint on rapid 20 e reference 20701 for the serratia species.This complaint led to an investigation; however, customer problem wasn't reproduced internally.No other complaint was registered on the lot number 1005589130.Review of the lot record indicated no batch event impacting the performance of the lot 1005589130.As api rapid 20 e lot number 1005589130 was expired at the time of investigation, no further investigation was possible.

• Brand Name: API® RAPID 20 E
• Common Device Name: API® RAPID 20 E STRIP
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9076609
• Report Number: 9615754-2019-00087
• Device Sequence Number: 2852717
• Product Code: JSS
• UDI-Device Identifier: 03573026048617
• UDI-Public: 03573026048617
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 09/18/2018
• Device Catalogue Number: 20701
• Device Lot Number: 1005589130
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1