TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	75	75
Low Test Results	39	39
Non Reproducible Results	25	25
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Appropriate Term/Code Not Available	5	5
Patient Device Interaction Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Low Readings	4	4
Use of Device Problem	3	3
Device Handling Problem	3	3
Incorrect Measurement	3	3
Output Problem	2	2
Erratic Results	2	2
Chemical Problem	1	1
Device Ingredient or Reagent Problem	1	1
Mechanical Problem	1	1
Crack	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Imprecision	1	1
Sharp Edges	1	1
Calibration Problem	1	1
No Apparent Adverse Event	1	1
False Positive Result	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
Insufficient Information	13	13
No Known Impact Or Consequence To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Laceration(s)	4	4
Head Injury	2	2
Bone Fracture(s)	2	2
Abrasion	2	2
No Consequences Or Impact To Patient	2	2
No Code Available	1	1
Test Result	1	1
Crushing Injury	1	1
Pain	1	1
Muscle/Tendon Damage	1	1
Eye Injury	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Biomedical GmbH	II	Sep-05-2024
2	Beckman Coulter Inc.	II	Oct-14-2021
3	Beckman Coulter, Inc.	II	Jul-11-2025