MAUDE Adverse Event Report: HOLOGIC INCORPORATED PANTHER INSTRUMENT; IN-VITRO DIAGNOSTIC

Catalog Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Virus (2136)

Event Date 07/20/2020

Event Type  Injury  

Event Description

Hologic received a medical device reporting (mdr) letter from the food and drug administration (fda) with reference # mw5095707, dated july 31, 2020 concerning a patient sample that was tested on the hologic panther platform that yielded a positive result for covid-19 but produced a negative result when tested on the luminex aries platform.The sample was then retested twice on the hologic panther and the luminex aries platform.Both the retests on the hologic platform produced positive results and the luminex aries platform produced negative results.In addition, the patient had an antibody test that was positive, thereby hologic's test result is consistent.The issued mdr letter is against the luminex aries product and not against a hologic product, hence no further action is needed for this complaint.

• Brand Name: PANTHER INSTRUMENT
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego, ca
• Manufacturer (Section G): HOLOGIC INC.; 10210 genetic center drive san; san diego, ca
• Manufacturer Contact: abel saluta ; 10210 genetic center drive san; san diego, ca ; 4108506
• MDR Report Key: 10484975
• MDR Text Key: 205461653
• Report Number: 2024800-2020-00007
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: N/A
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other